Devices and methods for competency training and use authorization for dispensing an agent

ABSTRACT

Devices and methods for competency training and use authorization for dispensing an agent are described, which include: an agent-dispensing device including a reservoir configured to store agents, a controllable agent-dispensing mechanism in communication with the reservoir, a locking mechanism coupled to the controllable agent-dispensing mechanism, a microprocessor including circuitry, use sensors to monitor at least one operational step for use of the agent-dispensing device, training circuitry configured to train the user and to assign a value for each of the monitored at least one operational step for use of the agent-dispensing device, verification circuitry configured to determine if the assigned value for each of the monitored at least one operational step for use of the agent-dispensing device meets or exceeds a pre-defined performance threshold, and activation circuitry responsive to the verification circuitry and configured to deactivate the locking mechanism to allow dispensing of agents if the assigned value meets or exceeds the pre-defined performance threshold.

If an Application Data Sheet (ADS) has been filed on the filing date ofthis application, it is incorporated by reference herein. Anyapplications claimed on the ADS for priority under 35 U.S.C. §§119, 120,121, or 365(c), and any and all parent, grandparent, great-grandparent,etc. applications of such applications, are also incorporated byreference, including any priority claims made in those applications andany material incorporated by reference, to the extent such subjectmatter is not inconsistent herewith.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit of the earliest availableeffective filing date(s) from the following listed application(s) (the“Priority Applications”), if any, listed below (e.g., claims earliestavailable priority dates for other than provisional patent applicationsor claims benefits under 35 USC §119(e) for provisional patentapplications, for any and all parent, grandparent, great-grandparent,etc. applications of the Priority Application(s)). In addition, thepresent application is related to the “Related Applications,” if any,listed below.

PRIORITY APPLICATIONS

None

RELATED APPLICATIONS

U.S. patent application Ser. No. 13/873,991, entitled SYSTEMS ANDMETHODS FOR COMPETENCY TRAINING AND USE AUTHORIZATION FOR DISPENSING ANAGENT, naming MICHAEL H. BAYM, JESSE R. CHEATHAM, III, PHILIP A.ECKHOFF, RODERICK A. HYDE, JORDIN T. KARE, AND LOWELL L. WOOD, JR. asinventors, filed 30, Apr. 2013, is related to the present application.

If the listings of applications provided above are inconsistent with thelistings provided via an ADS, it is the intent of the Applicant to claimpriority to each application that appears in the Priority Applicationssection of the ADS and to each application that appears in the PriorityApplications section of this application.

All subject matter of the Priority Applications and the RelatedApplications and of any and all parent, grandparent, great-grandparent,etc. applications of the Priority Applications and the RelatedApplications, including any priority claims, is incorporated herein byreference to the extent such subject matter is not inconsistentherewith.

SUMMARY

In an aspect, a system for competency training and use authorization fordispensing an agent includes, but is not limited to: an agent-dispensingdevice configured to dispense one or more agents to a user, theagent-dispensing device including a controllable agent-dispensingmechanism; the agent-dispensing device including a receiver configuredto receive a signal and to activate or deactivate a locking mechanismcoupled to the controllable agent-dispensing mechanism; a computingdevice having a display and a user interface; and a web-basedinteractive tool including stored text, images, audio, or videoaccessible to the user on the computing device, the web-basedinteractive tool including a training module to provide training to theuser in proper use of the agent-dispensing device; a verification moduleto verify a competency of the user in the proper use of theagent-dispensing device; and an activation module responsive to theverification module and operable to provide an activation signal to thereceiver to deactivate the locking mechanism to allow dispensing of theone or more agents from the agent-dispensing device after verifying thecompetency of the user. In addition to the foregoing, other systemaspects are described in the claims, drawings, and text forming a partof the present disclosure.

In an aspect, a method of verifying user competency of anagent-dispensing device includes, but is not limited to: providing aweb-based interactive tool to a user through a computing device, theweb-based interactive tool including stored text, images, audio, and/orvideo, and a training module to provide training to the user in properuse of the agent-dispensing device, a verification module to verify acompetency of the user in the proper use of the agent-dispensing device,and an activation module responsive to the verification module andoperable to provide an activation signal to deactivate a lockingmechanism of the agent-dispensing device; training the user in theproper use of the agent-dispensing device using the training module ofthe web-based interactive tool; verifying a competency of the user inthe proper use of the agent-dispensing device using the verificationmodule of the web-based interactive tool; and activating theagent-dispensing device with the activation module of the web-basedinteractive tool by providing the activation signal to deactivate thelocking mechanism to allow dispensing of one or more agent from theagent-dispensing device after verifying the competency of the user inthe proper use of the agent-dispensing device. In addition to theforegoing, other method aspects are described in the claims, drawings,and text forming a part of the present disclosure.

In an aspect, a computer implemented method for authorizing use of anagent-dispensing device following competency training includes, but isnot limited to: connecting a user to a web-based interactive toolthrough a bi-directional communication network link; receivingauthorization information associated with the user through thebi-directional communication network link; authenticating the user as anauthorized candidate for competency training; selecting a trainingmodule from the web-based interactive tool corresponding to thecompetency training which the user is authorized to access; executing aset of at least one skill-based simulated training softwarecorresponding to the training module selected from the web-basedinteractive tool; generating a set of training results for the user uponcompletion of the training module; certifying the user is competent touse the agent-dispensing device if the set of training results for theuser meets or exceeds a pre-defined performance threshold; and issuingover the bi-directional communication network link an authorization keyto the user to allow the user to deactivate a locking mechanismassociated with a controllable agent-dispensing mechanism of theagent-dispensing device. In addition to the foregoing, other methodaspects are described in the claims, drawings, and text forming a partof the present disclosure.

In an aspect, an agent-dispensing device includes, but is not limitedto: a housing including at least one reservoir configured to store oneor more agents; a controllable agent-dispensing mechanism incommunication with the at least one reservoir; a locking mechanismcoupled to the controllable agent-dispensing mechanism; a microprocessorincluding instructions for operating the agent-dispensing device in adispensing mode or a training mode; one or more use sensors configuredto monitor at least one operational step for use of the agent-dispensingdevice in the training mode; training circuitry configured to train theuser in the at least one operational step for use of theagent-dispensing device and to assign a value for each of the monitoredat least one operational step for use of the agent-dispensing device inthe training mode; verification circuitry configured to determine if theassigned value for each of the monitored at least one operational stepfor use of the agent-dispensing device in the training mode meets orexceeds a pre-defined performance threshold; and activation circuitryresponsive to the verification circuitry and configured to deactivatethe locking mechanism to allow dispensing of the one or more agents ifthe assigned value for each of the monitored at least one operationalstep for use of the agent-dispensing device in the training mode meetsor exceeds the pre-defined performance threshold. In addition to theforegoing, other device aspects are described in the claims, drawings,and text forming a part of the present disclosure.

In an aspect, a method of verifying user competency implemented withcircuitry in an agent-dispensing device includes, but is not limited to:authenticating a user as an authorized user of the agent-dispensingdevice, wherein the agent-dispensing device includes at least one ofauthorization circuitry, training circuitry, one or more use sensors,verification circuitry, or activation circuitry; training the user in atleast one operational step for use of the agent-dispensing device withone or more training instructions included in the training circuitry;monitoring the user's performance of the at least one operational stepfor use of the agent-dispensing device with the one or more use sensors;assigning a value to each of the monitored at least one operation stepfor use of the agent-dispensing device performed by the user; verifyingwith the verification circuitry if the assigned value for each of themonitored at least one operational step for use of the agent-dispensingdevice meets or exceeds a pre-defined performance threshold; activatingthe agent-dispensing device with activation circuitry responsive to theverification circuitry to allow dispensing of one or more agents fromthe agent-dispensing device if the assigned value for each of themonitored at least one operational step for use of the agent-dispensingdevice meets or exceeds the pre-defined performance threshold. Inaddition to the foregoing, other method aspects are described in theclaims, drawings, and text forming a part of the present disclosure.

The foregoing summary is illustrative only and is not intended to be inany way limiting. In addition to the illustrative aspects, embodiments,and features described above, further aspects, embodiments, and featureswill become apparent by reference to the drawings and the followingdetailed description.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a schematic of an embodiment of a system for competencytraining and use authorization for dispensing an agent.

FIG. 2 is a schematic illustrating an embodiment of an agent-dispensingdevice.

FIG. 3 is a schematic illustrating further aspects of an embodiment ofan agent-dispensing device such as shown in FIG. 2.

FIG. 4 is a schematic illustrating further aspects of an embodiment ofan agent-dispensing device such as shown in FIG. 2.

FIG. 5 is a schematic of an embodiment of a computing device.

FIG. 6 is a schematic of an embodiment of a web-based interactive tool.

FIG. 7 is a schematic of an embodiment of a web-based interactive tool.

FIG. 8 is a schematic of an embodiment of a system for competencytraining and use authorization including an image capture device.

FIG. 9 is a schematic of an embodiment of a system of competencytraining and use authorization including use sensors on anagent-dispensing device.

FIG. 10 is a schematic of an embodiment of a web-based interactive tool.

FIG. 11 is a schematic of an embodiment of a web-based interactive tool.

FIG. 12 is a schematic of an embodiment of a web-based interactive tool.

FIG. 13 is a schematic of an embodiment of a system for competencytraining and use authorization including a separate training device.

FIG. 14 is a schematic of an embodiment of a system for competencytraining and use authorization including a combined agent-dispensingdevice and computing device.

FIG. 15 is a schematic illustrating an embodiment of an agent-dispensingdevice.

FIG. 16 is a schematic illustrating further aspects of an embodiment ofan agent-dispensing device such as shown in FIG. 15.

FIG. 17 is a schematic illustrating further aspects of an embodiment ofan agent-dispensing device such as shown in FIG. 15.

FIG. 18 is a flowchart of a method of verifying user competency of anagent-dispensing device.

FIG. 19 is a flowchart illustrating further aspects of a method such asshown in FIG. 18.

FIG. 20 is a flowchart showing further aspects of a method such asdepicted in FIG. 18.

FIG. 21 is a flowchart depicting further aspects of a method such asillustrated in FIG. 18.

FIG. 22 is a flowchart illustrating further aspects of a method such asshown in FIG. 18.

FIG. 23 is a flowchart showing further aspects of a method such asdepicted in FIG. 18.

FIG. 24 is a flow diagram illustrating a method of verifying usercompetency of an agent-dispensing device.

FIG. 25 is a flow diagram illustrating a method of verifying usercompetency of an agent-dispensing device.

FIG. 26 is a flowchart of a method of verifying user competencyimplemented with circuitry in an agent-dispensing device.

FIG. 27 is a flowchart of a computer-implemented method of authorizinguse of an agent-dispensing device following competency training.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings, which form a part hereof. In the drawings,similar symbols typically identify similar components, unless contextdictates otherwise. The illustrative embodiments described in thedetailed description, drawings, and claims are not meant to be limiting.Other embodiments may be utilized, and other changes may be made,without departing from the spirit or scope of the subject matterpresented here.

With reference to FIG. 1, shown is a schematic view of a system 100 forcompetency training and use authorization for dispensing an agent.System 100 includes agent-dispensing device 110 and computing device 150and web-based interactive tool 160 accessible to user 195 throughcomputing device 150. Agent-dispensing device 110 is configured todispense one or more agents to user 195 and includes controllableagent-dispensing mechanism 120 and receiver 140 configured to receive asignal 145 and to activate or deactivate locking mechanism 130 coupledto controllable agent-dispensing mechanism 120. Computing device 150further includes display 152 and user interface 154. Web-basedinteractive tool 160 includes training module 170 to provide training touser 195 in proper use of agent-dispensing device 110, verificationmodule 180 to verify a competency of user 195 in the proper use ofagent-dispensing device 110, and activation module 190 responsive toverification module 180 and operable to provide an activation signal 145to receiver 140 to deactivate locking mechanism 130 to allow dispensingof one or more agents from agent-dispensing device 110 after verifyingthe competency of user 195.

System 100 includes components and features for training a user in theproper use of an agent-dispensing device and any agent contained ordispensed from said agent-dispensing device. System 100 also includescomponents and features for verifying the competency of the user in theproper use of an agent-dispensing device and/or any agent contained ordispensed from said agent-dispensing device prior to deactivating alocking mechanism associated with the controllable agent-dispensingmechanism of the device. In this way, only a competent user(s) isallowed access to the contents of the agent-dispensing device.

In one embodiment, user 195 is trained using web-based interactive tool160 to self-administer one or more agents from agent-dispensing device110. For example, user 195 may be trained, training verified, andlocking mechanism 130 of agent-dispensing device 110 deactivated usingweb-based interactive tool 160 to allow self-administration of a highlyregulated prescription pain medication, e.g., oxycodone. For example,user 195 may live in a remote location, receive an agent-dispensingdevice in the mail, e.g., by certified mail, with instructions foraccessing web-based interactive tool 160 through the Internet using acomputing device.

In one embodiment, user 195 is trained using web-based interactive tool160 to administer one or more agents from agent-dispensing device 110 toone or more other individuals. For example, user 195 may be a caregiver,e.g., an aid worker, in a remote location who is trained, trainingverified, and locking mechanism 130 of agent-dispensing device 110deactivated using web-based interactive tool 160 accessed via theInternet to administer one or more agents, e.g., a vaccine, to one ormore individuals in the remote location, e.g., a developing country. Forexample, user 195 may be a user attending to a sick family member, e.g.,a child or a parent, in a remote location, e.g., at a distance from amedical facility, who is trained, training verified, and the lockingmechanism of an agent-dispensing device deactivated using the web-basedinteractive tool, to administer an opioid pain reliever, e.g., morphine,to the sick family member. In one embodiment, the user can includeindividuals who are otherwise not medically trained but are authorizedto administer an agent to either themselves or other individuals afterproper training and verification using the web-based interactive tool.

System 100 includes agent-dispensing device 110. Agent-dispensing device110 is configured to controllably dispense one or more agent forpreventing and/or treating a disease or medical condition. In oneembodiment, the one or more agents include one or more therapeuticagents. In one embodiment, the one or more agents include one or morepreventative agents. Non-limiting examples of diseases and/or conditionsinclude but are not limited to cardiovascular disorders, renaldisorders, metabolic disorders, neurodegenerative disorders,psychological disorders, neuromuscular and pain disorders,gastrointestinal disorders, gynecological and urological disorders,cancer, inflammation, autoimmune disorders, dermatological disorders,microbial infections and the like.

Agent-dispensing device 110 is configured to controllably dispense oneor more agents upon activation of the agent-dispensing device inresponse to verification that the user is qualified to use theagent-dispensing device, the one or more agents, or any associatedagent-containing cartridges. In one embodiment, agent-dispensing device110 includes one or more reservoirs including one or more agents fortreating and/or preventing one or more disease and/or condition. In oneembodiment, agent-dispensing device 110 includes one or more receptacleor docking site configured to accept one or more agent-containingcartridges. The agent-containing cartridges can be filled with one ormore agents for treating and/or preventing one or more disease and/orcondition.

Agent-dispensing device 110 can include one or more of an injectiondevice, an inhalation device, a solid form dispensing device, a liquidform dispensing device, a gas form dispensing device, or a transdermaldispensing device. In one embodiment, agent-dispensing device 110 isconfigured for intranasal administration of a therapeutic orpreventative agent. In one embodiment, agent-dispensing device 110 isconfigured for vaginal or rectal administration of a therapeutic orpreventative agent. In general, agent-dispensing device 110 can beconfigured to administer one or more agents to one or more of an ear, anostril, a mouth, a throat, a lung, skin, ureter, vagina, or rectum. Inone embodiment, agent-dispensing device 110 can be a smart pill intendedfor oral ingestion or rectal insertion. In one embodiment,agent-dispensing device 110 is implantable. In one embodiment,agent-dispensing device 110 is sized for placement into either thevascular or lymphatic system. In one embodiment, agent-dispensing device110 is a self-contained, handheld device containing all of thecomponents needed for activation and controllable release of one or moretherapeutic or preventative agents. In one embodiment, agent-dispensingdevice 110 may include a mobile, e.g., hand-held or implantablecomponent in wired or wireless communication with a less-mobile controlcomponent. For example, the mobile component may include a controllableagent-dispensing mechanism, a locking mechanism, a receiver and its ownpower source while the less-mobile control component may include controlcircuitry, a transmission unit, a power source, and any of a number ofother components. For example, the mobile component may be asyringe-like dispensing device in wireless communication with atable-top control unit. The table-top control unit may further includethe computing device on which the web-based interactive tool is accessedto facilitate training and verification prior to activation of thesystem for authorized agent dispensing. In one embodiment,agent-dispensing device 110 may include an implantable portion inwireless communication with a hand-held portion, e.g., a personalelectronic device, the latter of which may serve as the computing devicecapable of accessing the web-based interactive tool to provide trainingand verification for the user and activation of the implanted portion ofthe system.

Agent-dispensing device 110 includes controllable agent-dispensingmechanism 120. Controllable agent-dispensing mechanism 120 can includeany of a number of means for dispensing a therapeutic or preventativeagent for treating and/or preventing a disease and/or condition.Non-limiting examples of controllable agent-dispensing mechanismsinclude one or more of an inhalation dispensing mechanism, an injectiondispensing mechanism, an intranasal dispensing mechanism, a rectaldispensing mechanism, an intravaginal dispensing mechanism, atransdermal dispensing mechanism, a solid form dispensing mechanism, aliquid form dispensing mechanism, or a gas form dispensing mechanism.

In one embodiment, controllable agent-dispensing mechanism 120 includesan inhalation dispensing mechanism. Non-limiting examples of inhalationdispensing mechanisms include dry powder inhalation, nebulization, ormetered-dose inhalation. For example, agent-dispensing device 110 mayinclude controllable agent-dispensing mechanism 120 that is ametered-dose inhalation dispensing mechanism for use in administering aninhaled agent, e.g., a corticosteroid and/or beta-adrenoceptor agonist,for treating asthma or chronic obstructive pulmonary disease.Non-limiting examples of inhaler devices including processors andcircuitry are described in U.S. Patent Application 2006/0130828; U.S.Patent Application 2007/0074722; which are incorporated herein byreference.

In one embodiment, controllable agent-dispensing mechanism 120 includesan injection dispensing mechanism. The injection dispensing mechanismcan include needle or needleless injection dispensing mechanisms. In oneembodiment, controllable agent-dispensing mechanism 120 can include oneor more retractable injection needles. For example, one or more needlesmay be retracted into agent-dispensing device 110 until an activationsignal is sent to deactivate a locking mechanism to allow extension ofthe one or more needles. In one embodiment, controllableagent-dispensing mechanism 120 may control passage of an injectableagent through the one or more needles. For example, the controllableagent-dispensing mechanism may include a plunger for forcing aninjectable agent through the one or more needles, the plunger onlyfunctional when an activation signal has been sent to the receiver todeactivate a locking mechanism associated with the plunger. For example,the controllable agent-dispensing mechanism may include a needlelessinjection system, e.g., a jet-injection system, for use in administeringa vaccine. A non-limiting example of a jet injection system is describedin Kim & Prausnitz, Curr. Top. Microbiol. Immunol. (2012) 351:77-112,which is incorporated herein by reference. Other non-limiting examplesof injectors include single needle injector, multi-needle injector, ormicro-needles. The needles can be part of an injector device, e.g., asyringe-like device, or part of a patch, e.g., a transdermal patch withmicro-needles. Other non-limiting examples of injection mechanismsconfigured for dispensing a therapeutic and/or preventative agentinclude microject injection mechanisms (see, e.g., Arora et al., Proc.Natl. Acad. Sci. (2007) 104:4255-4260, which is incorporated herein byreference) and needle free injection mechanisms (see, e.g., Brearley etal., BMC Clinical Pharmacology (2007) 7:10; 1472-6904/7/10, which isincorporated herein by reference). A non-limiting example of an injectorwith a processor is described in U.S. Pat. No. 6,997,911, which isincorporated herein by reference.

In one embodiment, controllable agent-dispensing mechanism 120 includesan intranasal dispensing mechanism. The intranasal dispensing mechanismcan include snorting a liquid or dry powder, liquid drops using asyringe or a dropper, squeeze bottle delivery, sprayed or atomizeddelivery, or nebulized delivery. In one embodiment, controllableagent-dispensing mechanism 120 may include a controllable opening in aportion of agent-dispensing device 110 that is inserted into a nasalpassage, the controllable opening only open when an activation signalhas been sent to the receiver to deactivate a locking mechanism.

In one embodiment, controllable agent-dispensing mechanism 120 includesa transdermal dispensing mechanism. Examples of transdermal dispensingmechanisms include, but are not limited to, passive and activedispensing mechanisms. An example of a passive dispensing mechanismincludes release from one or more reservoirs associated withagent-delivery device of one or more agents capable of being passivelyabsorbed through the skin. Non-limiting examples include any of a numberof agents formulated for use in a transdermal patch, e.g., estrogen,testosterone, analgesics, or nicotine. Non-limiting examples of anactive dispensing mechanism includes ionophoresis, electroporation, ormicroprojections to actively transport one or more agents through theskin. For example, agent-dispensing device 110 may be a transdermalpatch with an active controllable agent-dispensing mechanism 120, e.g.,an iontophoretic patch, which controllably releases an agent, e.g., ananalgesic agent for mitigating pain, across the dermal layer. Anon-limiting example of an iontophoretic transdermal patch is describedin Kasha et al., Drug Discov. Ther. (2012) 6:256-262, which isincorporated herein by reference.

In one embodiment, agent-dispensing device 110 includes an oral drugdispenser. For example, agent-dispensing device 110 may hold one or moreorally administered agents, e.g., a pill or oral solution, that arecontrollably released from agent-dispensing device 110 after training,verification, and activation.

In one embodiment, controllable agent-dispensing mechanism 120 includesa solid form or liquid form dispensing mechanism for dispensing one ormore agents that are orally administered. In one embodiment,controllable agent-dispensing mechanism 120 includes a pill dispensingmechanism. Non-limiting examples of solid form or liquid form dispensingmechanisms include gates, doors, valves, pores, conveyor belts, etc. Forexample, agent-dispensing device 110 may include one or more orallyadministered agents, e.g., pills or oral solution, which arecontrollably released using a controllable agent-dispensing mechanisms,e.g., one or more electrically responsive valves. In one embodiment, thecontrollable agent-dispensing mechanism 120 includes one or more lids toa pill box. For example, a single lid may cover a box including segmentsarranged per day or time of day, the controllable agent-dispensingmechanism revealing all of the doses of medication in a singleactivation signal. For example, each segment of a pill box may have aseparate lid that is revealed temporally or sequentially in response toone or more activation signals. Non-limiting examples of pill dispenserswith controllers and/or circuitry include U.S. Patent Application2011/0166700 and U.S. Patent Application 2013/0002795, which areincorporated herein by reference.

Agent-dispensing device 110 further includes a locking mechanism 130coupled to controllable agent-dispensing mechanism 120 and capable ofbeing activated or deactivated in response to providing activationsignal 145 to receiver 140. Locking mechanism 130 can include any of anumber of means for preventing actuation of controllableagent-dispensing mechanism 120 or release of one or more agents fromagent-dispensing device 110. Non-limiting examples of locking mechanismsinclude camshaft-driven locking mechanism, spring loaded bar, bar/slide,retractable pin, latch, or hook which may be electrically, optically, ormagnetically actuated in response to an activation signal. Non-limitingexamples of dispensing devices with locking mechanism are described inU.S. Patent Application 2007/0074722 and U.S. Patent Application2009/0276090, which are incorporated herein by reference.

Agent-dispensing device 110 further includes receiver 140. Receiver 140is operably connected to at least one antenna and is configured toreceive input signals, e.g., an activation signal sent to deactivatelocking mechanism 130 to allow dispensing of the one or more agents fromagent-dispensing device 110 after verifying the competency of the user.Receiver 140 can include an audio receiver, a radio receiver, an opticalreceiver, a magnetic receiver, an electronic receiver, or the like.

Returning to FIG. 1, system 100 includes computing device 150 includingdisplay 152 and user interface 154. Computing device 150 is able toaccess web-based interactive tool 160 through the Internet or othernetworking means to train and verify a competency of a user and toactivate agent-dispensing device 110. Computing device 150 can takevarious forms or be part of an object, and can include, but not limitedto, a computer, a laptop computer, a personal electronic device, adedicated computing device, a limited resource computing device, awireless communication device, a mobile wireless communication device,an electronic pen, a handheld electronic writing device, a tablet, adigital camera, a scanner, an ultrasound device, an x-ray machine, anon-invasive imaging device, a cell phone, a PDA, an electronic tabletdevice, a medical apparatus (implantable or otherwise), a printer, orany other like device that takes information as an input and gives itback to the end-users. Computing device 150 can include a digital singleprocessor, ASIC, microprocessor, or other type of processor operating ona system such as a personal computer, server, a router, of other devicecapable of processing data including network interconnection device. Inone embodiment, computing device 150 and agent-dispensing device 110 areincorporated into a single device, e.g., a smart phone withagent-dispensing capabilities.

Upon completion of training and verification of competency, anactivation signal 145 is provided to receiver 140 to deactivate lockingmechanism 130 to allow dispensing of one or more agents fromagent-dispensing device 110. Activation signal 145 can include wired orwireless signals. For example, activation signal 145 may be carried onan electrical wire. For example, agent-dispensing device 110 can beconnected to computing device 150 through an electrical connection,e.g., a wired connection, and an electrical signal sent to deactivatelocking mechanism 130 on agent-dispensing device to allow dispensing ofone or more agents following verification of competency of the user. Forexample, activation signal 145 may be carried on wireless radio waves.Activation signal 145 can include signals carried as electromagneticwaves, e.g., radio waves, microwave, infrared, or optical. For example,computing device can include a built-in wireless transmitter or accept awireless adaptor for translating information, e.g., an activationsignal, into a radio signal that is wirelessly transmitted and receivedby receiver 140 of agent-dispensing device 110. In one embodiment,activation signal 145 can include magnetic signals. In one embodiment,activation signal 145 can include electrical signals. In one embodiment,activation signal 145 can include an acoustic signal. Non-limitingexamples of dispensing devices with communication links to a computingdevice are described in U.S. Patent Application 2009/0074262 and U.S.Patent Application 2008/0114299, which are incorporated herein byreference.

In one embodiment, activation signal 145 is indirectly provided toreceiver 140 of agent-dispensing device 110. For example, activationsignal 145 may be provided to receiver 140 in response to entering anactivation code provided to the user following training andverification. For example, activation signal 145 may be provided toreceiver 145 in response to scanning or capturing an image of a code,e.g., a bar code or QR code, displayed on a display of the computingdevice following training and verification.

Computing device 150 is configured to run web-based interactive tool 160to train and verify the competency of user 195 and to deactivate lockingmechanism 130 of agent-dispensing device 110 once competency has beenverified. Web-based interactive tool 160 includes one or more of text,images, audio and/or video designed to train and verify a competency ofa user in the proper use of an agent-dispensing device. In oneembodiment, web-based interactive tool 160 can include a series ofwebpages or screen shots including text, images, audio and/or videotraining, verification, and authorization components for authorizing useof agent-dispensing device 110 by a user. In one embodiment, each of thewebpages or screen shots can be written in plain text interspersed withformatting instructions, e.g., Hypertext Markup Language (HTLM, XHTLM).For example, web-based interactive tool 160 may contain text displayedon display 152 of computing device 150 that describes the proper use andcare of agent-dispensing device 110 and/or any associated agent intendedfor use with agent-dispensing device 110. For example, web-basedinteractive tool 160 may include a video stream of an actordemonstrating proper use and care of agent-dispensing device 110 andconfigured for viewing on display 152 of computing device 150.

In one embodiment, web-based interactive tool 160 is downloaded from theInternet directly onto computing device 150. In one embodiment,web-based interactive tool 160 is accessible on computing device 150 viacloud computing. In one embodiment, web-based interactive tool 160 isdownloaded to non-transitory machine readable media, e.g., a compactdisk or flash-drive, and the non-transitory machine readable media usedby computing device 150 as the source of web-based interactive tool 160.In one embodiment, web-based interactive tool 160 is completelycontained in a dedicated computing device operably connected to theagent-dispensing device, e.g., incorporated into the agent-dispensingdevice. In one embodiment, web-based interactive tool 160 is downloadedonto computing device 150 from a disk, USB drive, or other mediumcapable of storing and transferring a software application.

In one embodiment, web-based interactive tool 160 is run from a remoteserver in a location remote from the user. In one embodiment, the remoteserver can include a series of one or more servers in one or morelocations remote from the user. In one embodiment, the remote server isa mainframe computer in a location remote from the user. The remoteserver can be part of a computer network, web service, cloud-basedinfrastructure, or the like. In one embodiment, web-based interactivetool 160 is accessed through the World Wide Web. In one embodiment,web-based interactive tool 160 can be accessed through a web browser,e.g., Google, Chrome, Firefox, Internet Explorer, or Safari. In oneembodiment, web-based interactive tool 160 is accessed through a widearea network (WAN). In one embodiment, web-based interactive tool 160 isaccessed through a local area network (LAN). In one embodiment,web-based interactive tool 160 is accessed through a virtual privatenetwork (VPN) for private communication with, e.g., a pharmacy, apharmaceutical company, or medical facility that manages the web-basedinteractive tool and its content. In one embodiment, web-basedinteractive tool 160 is accessed using an Internet address, e.g., aUniform Resource Locator (URL).

In one embodiment, web-based interactive tool 160 is accessed from aremote server associated with a government agency or organization, e.g.,the Food and Drug Administration (FDA), Centers for Disease Control(CDC), or a local/state/national public health department. In oneembodiment, the remote server is associated with the World HealthOrganization (WHO). In one embodiment, the remote server can be locatedat an international site, e.g., in a country distinct from the countryin which the agent-dispensing device is used. For example, the remoteserver could be located in an industrialized/developed country, e.g.,the United States or Europe and allowing access to web-based interactivetool 160 to a user in a developing country, e.g., a West Africancountry, via the Internet, satellite phone, or other communicationslink. For example, the system including web-based interactive tool 160could be used to remotely train, verify, and authorize an individual inuse of an agent-dispensing device for dispensing a vaccine or otheragent in a developing country.

In some embodiments, the web-based interactive tool 160 is hostedinternally on an organization's server. For example, the web-basedinteractive tool may be accessed from a server associated with or hostedby a government agency, e.g., the FDA, the CDC, or other public healthorganization, a pharmaceutical company, a pharmacy, a hospital, orclinic. In some embodiments, the web-based interactive tool is hostedexternally on a public or private cloud server accessible by a userthrough the Internet.

In one embodiment, web-based interactive tool 160 is accessed via one ormore of public, community, private, or hybrid cloud computing.Non-limiting examples of service providers for public cloudapplications, storage, and other resources through the Internet includeAmazon AWS, Microsoft, or Google. In one embodiment, web-basedinteractive tool 160 is accessed through a community cloudinfrastructure shared between several organizations from a specificcommunity with common concerns (e.g., security, compliance,jurisdiction, etc.), whether managed internally or by a third-party andhosted internally or externally. In one embodiment, web-basedinteractive tool 160 is accessed through a private cloud infrastructureoperated solely for a single organization, whether managed internally orby a third-party and hosted internally or externally. In one embodiment,web-based interactive tool 160 is accessed through a hybrid cloudcomposed of two or more clouds (private, community or public) thatremain unique entities but are bound together.

FIG. 2 illustrates further aspects of agent-dispensing device 110.Agent-dispensing device 110 includes controllable agent-dispensingmechanism 120, locking mechanism 130, and receiver 140 in housing 210.Housing 210 can take any of a number of forms, non-limiting examples ofwhich include a cylinder, a box, a disc, or the like. In one embodiment,housing 210 is handheld. For example, housing 210 including controllableagent-dispensing mechanism 120, locking mechanism 130, and receiver 140may be sized for use with one or more hands. In one embodiment, housing210 may be portable but sized for sitting on a surface. For example,housing 210 including controllable agent-dispensing mechanism 120,locking mechanism 130, and receiver 140 may be a box-like structuresized for sitting on a surface and configured to dispense one or moreagents, e.g., pills, once competency of the user has been verified.Other non-limiting examples of housing types include, but are notlimited to, an injector, an inhaler, a pill containing housing, a liquidcontaining housing, or a transdermal patch.

In one embodiment, receiver 140 is part of transmission unit 220.Transmission unit includes antenna 230 and is capable of both receivingand sending signals. For example, receiver 140 of transmission unit 220may be configured to receive an activation signal 145 to deactivatelocking mechanism 130 to allow dispensing of one or more agents throughcontrollable agent-dispensing mechanism 120. In one embodiment, atransmitter portion of transmission unit 220 may be configured totransmit one or more signals having information regarding the status ofagent-dispensing device 110, e.g., activated or inactivated, in anappropriate location, being used by an authorized user, and the like.

A “transmission unit,” as used herein, can be one or more of a varietyof units that are configured to send and/or receive signals, such assignals carried as electromagnetic waves. A transmission unit generallyincludes at least one antenna and associated circuitry. A transmissionunit can include a transmitter and a receiver. A transmission unit caninclude volatile or non-volatile memory. A transmission unit can includea processor and/or be operably connected to a processor. A transmissionunit can be operably connected to an energy source, such as a battery. Atransmission unit can include an energy harvesting unit, such as a unitconfigured to obtain energy from electromagnetic waves. A transmissionunit can include a transponder utilizing electromagnetic waves, forexample as described in “Fundamental Operating Principles,” in Chapter 3of the RFID Handbook: Fundamentals and Applications in Contactless SmartCards and Identification, Klaus Finkenzeller, John Wiley & Sons, (2003),which is incorporated herein by reference. A transmission unit caninclude an oscillator and encoder configured to generate a programmablepulse position-modulated signal in the radio frequency range (see, e.g.,U.S. Pat. No. 4,384,288, which is incorporated herein by reference). Atransmission unit can include a radio frequency identification device(RFID), which can be a passive RFID device, a semi-passive RFID device,or an active RFID device, depending on the embodiment (see, e.g., Chawla& Ha, “An Overview of Passive RFID,” IEEE Applications and Practice,11-17 (September 2007), which is incorporated herein by reference). Atransmission unit including an RFID device can be configured to transmitsignals in the UHF standard range. A transmission unit can include abattery-assisted passive RFID device, such as sold by Alien Technology®,Morgan Hill, Calif. A transmission unit can include an opticaltransmission unit. A transmission unit can include a hybrid backscattersystem configured to function in an RFID, IEEE 802.11x standard andBluetooth system (see, e.g., U.S. Pat. No. 7,215,976, which isincorporated herein by reference). A transmission unit can include anear field communication (NFC) device. A transmission unit can include aWireless Identification and Sensing Platform (WISP) device. Atransmission unit can be operably coupled to a data storage unit, forexample as described in U.S. Pat. No. 7,825,776 and US PatentApplication No. 2009/0243813, which are each incorporated herein byreference.

In one embodiment, agent-dispensing device 110 includes microprocessor250. Microprocessor 250 includes circuitry configured to control one ormore functions of agent-dispensing device 110 including but not limitedto controlling communication between various components ofagent-dispensing device 110, controlling communication with an externaldevice or entity, e.g., computing device 150, a training device, aremote server, the Internet; and controlling response to an activationsignal upon verification of a user's competency.

In one embodiment, microprocessor 250 is operably connected to powersource 260 and at least one of controllable agent-dispensing mechanism120, locking mechanism 130, and receiver 140. In one embodiment,microprocessor 250 includes central processing unit (CPU) ofagent-dispensing device 110. In one embodiment, microprocessor 250includes logic, memory and control circuitry configured to control oneor more functions of one or more components of agent-dispensing device110, e.g., controlling one or more functions of controllableagent-dispensing mechanism 120, locking mechanism 130, and/or receiver140. In one embodiment, microprocessor 250 may be part of amicrocontroller including a microprocessor, memory, clock, and I/Ocontrol. In one embodiment, microprocessor 250 includes embeddedsoftware configured to control one or more functions of agent-dispensingdevice 110. Non-limiting examples of dispensers with controllers aredescribed in U.S. Patent Application 2004/0074921; U.S. PatentApplication 2011/0166700; and U.S. Patent Application 2013/0002795,which are incorporated herein by reference.

Agent-dispensing device 110 optionally includes power source 260. Powersource 260 may be used to power one or more components ofagent-dispensing device 110, e.g., microprocessor 250, controllableagent-dispensing mechanism 120, locking mechanism 130, and receiver 140.In one embodiment, power source 260 includes nickel-cadmium,nickel-zinc, nickel-metal hydride, and/or lithium ion batteries. In oneembodiment, power source 260 includes a camera or watch sized alkaline,lithium, or silver-oxide battery or other appropriately sized andpowered battery. In one embodiment, the power source 260 is renewable,e.g., from solar sources, temperature differences, or vibration. In oneembodiment, power source 260 includes a thin-film fuel cell such as asolid oxide type (SOFC), a solid polymer type (SPFC), a proton exchangemembrane type (PEMFC), and/or substantially any combination thereof.Methods to fabricate such thin-film fuel cells are known and have beendescribed (see, e.g., U.S. Pat. No. 7,189,471, incorporated herein byreference). In one embodiment, power source 260 includes one or morestorage films that are configured for energy storage and energyconversion. Methods to fabricate such storage films are known and havebeen described (see, e.g., U.S. Pat. No. 7,238,628, incorporated hereinby reference). In one embodiment, power source 260 is a bio-basedbattery (see, e.g., U.S. Pat. No. 6,994,934, incorporated herein byreference). In one embodiment, power source 260 includes thin-filmbatteries. Methods to fabricate thin-film batteries, including thin filmmicrobatteries, are known and have been described (see, e.g., U.S. Pat.No. 7,194,801, which is incorporated herein by reference). In oneembodiment, one or more electromagnetic receivers (not shown) are usedto electromagnetically couple power to energize one or more componentsof agent-dispensing device 110 from an external power source. Methods toconstruct electromagnetic receivers have been described (see, e.g., U.S.Pat. No. 5,571,152), incorporated herein by reference.

Agent-dispensing device 110 optionally includes reservoir 270. In oneembodiment, reservoir 270 is an integral part of agent-dispensing device110 and is configured to store and dispense one or more agents. The oneor more agents can include one or more agents for preventing and/ortreating a disease and/or condition. The one or more agents stored inreservoir 270 can be in any of a number of physical forms, non-limitingexamples of which include gas, solid, liquid, or gel form. In oneembodiment, the one or more agents include solid form agents, e.g., oneor more of a pill, tablet, small particles, powder, or dissolvable film.

In one embodiment, reservoir 270 can include a single storage space fromwhich one or more agents are controllably released. For example,reservoir 270 can include a hollow space within agent-dispensing device110 configured to store and dispense one or more tablets. For example,reservoir 270 can include a fluid reservoir configured to store anddispense multiple doses of an injectable agent, e.g., insulin. In oneembodiment, reservoir 270 can include a separate storage space for eachagent to be stored and dispensed. For example, reservoir 270 can includetwo storage spaces, a first storage space containing agent X and asecond storage space containing agent Y. In one embodiment, reservoir270 can include a plurality of storage spaces from which each dose ofone or more agents is dispensed. For example, reservoir 270 may includea series of storage spaces, each storage space covered by a removableseal. In one embodiment, reservoir 270 can be configured to be refilled,e.g., having a resealable cover that can be removed by a user or otherindividual, e.g., a pharmacist, to refill reservoir 270 with one or moreagents. Refilling reservoir 270 with one or more agents that aredifferent from one or more agents previously stored and dispensed fromthe agent-dispensing device may trigger an update to what is provided tothe user in the web-based interactive tool, e.g., an update to thetraining and verification module to reflect the new one or more agentsintended for use with the agent-dispensing device.

Reservoir 270 of agent-dispensing device 110 is configured for storingand dispensing one or more agents for preventing and/or treating adisease or condition. In one embodiment, the one or more agents includeone or more therapeutic agents for preventing and/or treating a diseaseor condition. In one embodiment, the one or more agents include one ormore preventative agents for preventing and/or treating a disease orcondition. Non-limiting examples of therapeutic and/or preventativeagents include adrenoceptor agonists and antagonists (alpha blockers andbeta blockers), cholinoceptor agonists and antagonists, antihypertensiveagent, vasodilators, calcium channel blockers, sodium channel blockers,antihistamines, serotonin agonists and antagonists, ACE inhibitors,diuretics, angiotensin receptor blockers, vasoactive peptides,prostaglandins, thromboxanes, leukotriene inhibitors, nitric oxide,corticosteroids, benzodiazepines, barbiturates, antiseizure drugs,general and local anesthetics, muscle relaxants, analgesics,antipsychotics, antidepressants, anti-inflammatory agents, statins,hormones and hormone antagonists, antibacterial agents, antiviralagents, antifungal agents, and antiparasitic agents.

In one embodiment, the one or more agents include one or more vaccines.Non-limiting examples of vaccines include vaccines against small pox,hepatitis A, hepatitis B, polio, mumps, measles, rubella, diphtheria,pertussis, tetanus, haemophilus influenzae type B, chickenpox,rotavirus, influenza, meningococcal disease, pneumonia, typhoid,anthrax, yellow fever, and the like. It is anticipated that othervaccines currently in development for human immunodeficiency virus (HIV)and cancer, for example, will be of use in the systems and methodsdescribed herein.

In one embodiment, the one or more agents include one or more antidotesused to counteract the effects of a poison. Non-limiting examples ofantidotes (and associated poison) include adenosine (theophylline)atropine (nerve agents, mushrooms), calcium chloride (black widowspider), chelators (heavy metals), amyl nitrite (cyanide), deferoxamine(iron), naloxone hydrochloride (opioids), and antivenom (snake andinsect bites).

In one embodiment, the one or more agents include one or more controlledsubstances. Agents that are considered controlled substances under theControlled Substances Act (CSA) of the Comprehensive Drug AbusePrevention and Control Act of 1970 and codified under Title 21 Code ofFederal Regulations are divided into five schedules. Schedule IControlled Substances have no current medical use in the United States,a lack of accepted safety for use under medical supervision, and a highpotential for abuse. Non-limiting examples of Schedule I ControlledSubstances include heroin, lysergic acid diethylamide (LSD), marijuana,peyote, methaqualone, and 3,4-methylenedioxymethamphetamine. Schedule IIControlled Substances have a high potential for abuse, non-limitingexamples of which include hydromorphone, methadone, meperidine,oxycodone, fentanyl, morphine, opium, codeine, amphetamine,methamphetamine, methylphenidate, amobarbital, glutethimide, andpentobarbital. Schedule III Controlled Substances have a potential forabuse less than substances in Schedules I and II and may lead to low ormoderate physical dependence or high psychological dependence,non-limiting examples of which include low dose hydrocodone, codeinecontaining products, buprenorphine, benzphetamine, phendimetrazine,ketamine, and anabolic steroids. Schedule IV Controlled Substances havea low potential for abuse relative to substances in Schedule III,non-limiting examples of which include alprazolam, carisoprodol,clonazepam, clorazepate, diazepam, lorazepam, midazolam, temazepam, andtriazolam. Schedule V Controlled Substances have a low potential forabuse relative to substances listed in Schedule IV and consist primarilyof preparations containing limited quantities of certain narcotics,non-limiting examples of which include ezogabine and cough preparationscontaining not more than 200 milligrams of codeine per 100 millilitersor per 100 grams. An updated and complete list of the schedules forcontrolled substances is published annually in Title 21 Code of FederalRegulations (C.F.R.) §§1308.11 through 1308.15.

Agent-dispensing device optionally includes user-device interface 280.User-device interface 280 is configured to allow the user to interactwith agent-dispensing device 110. In one embodiment, user-deviceinterface 280 can be used to provide information from the device to theuser. For example, user-device interface 280 can be used to displayupdates on the status of agent-dispensing device 110, e.g., remainingpower level, dosages remaining, dispensing versus training mode, dosingschedule, cartridge currently inserted into the device, and the like. Inone embodiment, user-device interface 280 can be used to provideinformation from the user to the device. For example, user-deviceinterface 280 can be used to input information into agent-dispensingdevice such as, for example, an authorization code for use of theagent-dispensing device by an authorized user or an activation code fordeactivating the locking mechanism of the agent-dispensing device. Forexample, user-device interface 280 can be used to input additionalinformation including, but not limited to, user and/or patientinformation, a time, a date, a location, a type of agent being used, anage, a height, a weight, an activation code, and/or an authorizationcode.

User-device interface 280 can optionally include one or more of display281, touchpad 282, buttons 283, keypad 284, microphone 285, speaker 286,and/or image capture device 287. For example, display 281 and/or speaker286 can be used to transmit information, e.g., a device status update,to the user from agent-dispensing device 110. For example, display 281can be used in combination with touchpad 282, buttons 283, and or keypad284 to input information into agent-dispensing device 110. In oneembodiment, the user-device interface 280 can include touchpad 282 fordriving and/or pointing a cursor on display 281 of agent-dispensingdevice 110. Similarly, microphone 285 and/or image capture device 287can be used to input information into agent-dispensing device 110.

In one embodiment, display 281 is a type of segment display fordisplaying digits or alphanumeric characters, non-limiting examples ofwhich include seven-segment displays, fourteen-segment displays, orsixteen-segment displays. In one embodiment, the segments are composedof light emitting diodes (LEDs). In one embodiment, the segments arecomposed of liquid crystals. For example, display 281 may include aseven-segment display incorporated LEDs for displaying numbers and/ortext. For example, display 281 may display on/off indicator, time ofday, doses remaining, power usage and the like. In one embodiment,display 281 is a 2-dimensional display. Non-limiting examples oftechnologies and/or display types include LED display,electroluminescent display, electronic paper, plasma display, liquidcrystal display, organic LED display, surface-conductionelectron-emitter display, carbon nanotubes, quantum dot display, fieldemission display, or a ferro-liquid display. A non-limiting example ofan agent dispenser system with a display is described in U.S. PatentApplication 2013/0002795, which is incorporated herein by reference.

In one embodiment, the user-device interface 280 can include buttons283. In one embodiment, buttons 283 can include an “on/off” button. Inone embodiment, buttons 283 can include a “mode” button for changinginput modes shown on display 281. In one embodiment, buttons 283 include“up” or “down” arrows for scrolling through a menu of items displayed ondisplay 281. In one embodiment, buttons 283 can include an “enter”button to enter in a highlighted choice from a menu of options. In oneembodiment, buttons 283 can include one or more buttons associated witha keypad 284, for example spring-based buttons or virtual keys includingalphanumeric keys for entering text and/or numbers into agent-dispensingdevice 110.

In one embodiment, user-interface device 280 can include a touchscreenassociated with display 281. In one embodiment, user-interface device280 includes a single touch or multi-touch touchscreen technologyincorporated into display 281.

In one embodiment, user-interface device 280 can include an audio inputdevice, for example microphone 285. For example, a user may inputinformation into agent-dispensing device 110 using voice commands. Otheruser-interface devices include, but are not limited to a mouse, pendevices, knobs, switches, camera, fingerprint scanner, voicerecognition, and the like.

Agent-dispensing device 110 can optionally include user identificationcircuitry 290. User identification circuitry 290 is configured toreceive user identification input from user-device interface 280,compare the received user identification input with a set of storedauthorized user identification inputs, and verify the user as anauthorized user. Verifying the user as an authorized user can occur atany point in the process of using the agent-dispensing device. Anindication that the user is not an authorized user can lead a halt toany or all functions of the agent-dispensing device, e.g., power source260 may be shut off, receiver 140 may be shut off, or locking mechanism130 may no long be responsive to the activation signal, preventingdispensing of any or all agents from the device. In one embodiment, useridentification input can include an authorization code, e.g., a loginand password, specific for the user and recognizable as an authorizeduser identification input. For example, the user may receive a loginand/or password for authorized entry into the agent-dispensing devicefrom a physician, pharmacist, manufacturer, or other relevant entity,the login and/or password entered into the agent-dispensing device usingone or more of the user-device interfaces, e.g., display and keypad. Inone embodiment, user identification input can include a biometricparameter, e.g., a fingerprint scan or facial recognition, captured byone or more user-device interface, e.g., an image capture device. In oneembodiment, user identification input can include other biometricparameters including, but not limited to, voice recognition, DNAanalysis, or retinal scan. User identification circuitry 290 isconfigured to receive user input, compare with reference input, andverify that the user is an authorized user before allowing any agent tobe dispensed from the agent-dispensing device. Non-limiting examples ofdispensing devices with key code or biometric identification aredescribed in U.S. Pat. No. 7,072,738; U.S. Patent Application2006/0130828; U.S. Patent Application 2006/0130829; U.S. PatentApplication 2007/0186923; U.S. Patent Application 2008/0125724; U.S.Patent Application 2009/0276090, which are incorporated herein byreference.

FIG. 3 illustrates further embodiments of agent-dispensing device 110including a replaceable reservoir. Agent-dispensing device 110optionally includes housing 300. Housing 300 is configured in such a wayas to accept a replaceable reservoir, e.g., cartridge 320. In oneembodiment, housing 300 further includes docking site 310 sized foraccepting at least one cartridge 320 configured for storing anddispensing one or more agents. In one embodiment, docking site 310 caninclude one or more receptacles or openings defined by one or more wallsor surfaces of housing 300 into which at least one cartridge 320 is ableto be inserted. For example, docking site 310 may include a cylindricalspace configured to accommodate insertion of a cylindrical cartridge320. For example, docking site 310 may include a rectangular spaceconfigured to accommodate insertion of a rectangular cartridge 320. Inone embodiment, docking site 310 can include a male/female connector,e.g., a male portion of housing 300 configured to insert or snap into afemale portion of cartridge 320. In one embodiment, the male/femaleconnection is made at one or more outlets in the cartridge through whichone or more agents contained in the cartridge will eventually bedispensed. The one or more outlets may include a seal that is brokenupon forming the male/female connection. In one embodiment, docking site310 includes a groove into which an appropriately shaped portion ofcartridge 320 is able to slide and lock into place. In one embodiment,docking site 310 can include at least one magnetic surface configured tomagnetically interact with at least one magnetized surface of cartridge320. In one embodiment, a portion of docking site 310, e.g., a sharpbeveled tube forming an enclosed fluid channel, may puncture an outletinto cartridge 320 upon inserting cartridge 320 into docking site 310.For example, cartridge 320 can be a vial including a septum, the septumof the vial punctured by needle-like structure associated with dockingsite 310.

Agent-dispensing device 110 can accommodate one or more cartridges 320.Any given cartridge 320 includes one or more agents for preventingand/or treating a disease or condition. In one embodiment, the one ormore agents contained in cartridge 320 are released directly to the userfrom one or more controllable outlets associated with the cartridge. Inone embodiment, the one or more agents contained in cartridge 320 arereleased indirectly to the user through agent-dispensing device 110. Forexample, the one or more agents may be released into agent-dispensingdevice 110 from cartridge 320 and subsequently controllableagent-dispensing mechanism 120 is activated to release the one or moreagents from agent-dispensing device 110. In this way, the cartridgeitself does not need a controllable dispensing mechanism. For example,insertion of cartridge 320 into docking site 310 may penetrate a septumassociated with cartridge 320. However, it is intended that no agent isreleased until the agent-dispensing device is activated, e.g., afterlocking mechanism 130 of controllable agent-dispensing mechanism 120 isdeactivated following training and verification of competency of theuser. Cartridge 320 is primed to release material, e.g., a therapeuticor preventative agent, and may even release material into a holdingreservoir or chamber (not shown) associated with agent-dispensing device110 from which the material is ultimately released to the user inresponse to deactivation of the locking mechanism. In one embodiment,agent-dispensing device 110 may include an actuator that is activated bythe activation signal and triggers opening of an outlet on thecartridge.

Cartridge 320 can include any of a number of packaging forms appropriatefor storing and dispensing agents for treating and/or preventing adisease or condition. Non-limiting examples of packaging forms includeone or more of a pressurized canister, glass vial with septum, blisterpackage, other packaging with removable seals, aluminum can or bottle,antistatic bag, ampule, sachet, collapsible tube, flexible pouch,bottle, box, plastic bottle, pouch, or microchip. The one or more agentsstored in cartridge 320 can be in any of a number of physical forms,non-limiting examples of which include gaseous form, solid form, liquidor gel form. In one embodiment, the one or more agents include solidform agents, e.g., one or more of a pill, tablet, small particles,powder, or dissolvable film.

Cartridge 320 is configured for storing and dispensing one or moreagents for preventing and/or treating a disease or condition. In oneembodiment, the one or more agents include one or more therapeutic orpreventative agents for preventing and/or treating a disease orcondition, non-limiting examples of which have been described aboveherein. In one embodiment, the one or more agents include one or morevaccines, non-limiting examples of which have been described aboveherein. It is anticipated that other vaccines currently in developmentfor human immunodeficiency virus (HIV) and cancer, for example, will beof use in the systems and methods described herein. In one embodiment,the one or more agents include one or more antidotes used to counteractthe effects of a poison, non-limiting examples of which have beendescribed above herein. In one embodiment, the one or more agentsinclude one or more controlled substances, non-limiting examples ofwhich have been described above herein and are described in greaterdetail in Title 21 Code of Federal Regulations (C.F.R.) §§1308.11through §§1308.15.

In one embodiment, cartridge 320 can include a single storage space fromwhich one or more agents are controllably released. For example,cartridge 320 can include a replaceable canister configured to store anddispense multiple metered doses of an inhalant, e.g., the asthmamedication salbuterol or the flu vaccine FluMist®. For example,cartridge 320 can include a replaceable vial configured to store anddispense multiple doses of an injectable agent, e.g., insulin. In oneembodiment, cartridge 320 includes a separate storage space for eachagent to be stored and dispensed. For example, cartridge 320 include twostorage spaces, a first storage space containing agent X and a secondstorage space containing agent Y. In one embodiment, docking site 320 isconfigured to accept a first and second cartridge, the first cartridgeconfigured to store and dispense at least one first agent and the secondcartridge configured to store and dispense at least one second agent. Inone embodiment, cartridge 320 can include a plurality of storage spacesfrom which each dose of one or more agents is dispensed. For example,cartridge 320 may include a series of storage spaces, each storage spacecovered by a removable seal. Replacing cartridge 320 with a newcartridge containing one or more agents that differ from the one or moreagents in the replaced cartridge 320 may trigger an update to what isprovided to the user in the web-based interactive tool, e.g., an updatedtraining and verification module to reflect the new one or more agentsintended for use with the agent-dispensing device.

In one embodiment, agent-dispensing device 110 includes cartridgeidentification circuitry 330 configured to read a cartridgeidentification code, e.g., a radiofrequency tag or bar code, associatedwith the inserted cartridge. The cartridge identification code can beused to identify the one or more agents contained in the cartridge anddosing information. In one embodiment, the output of the trainingmodule, e.g., the type of information and/or instructions provided tothe user from the web-based interactive tool, is dependent upon the atleast one cartridge configured for storing and dispensing the one ormore agents. For example, agent-dispensing device 110 may be capable ofaccepting different types of cartridges containing different types ofagents. As such, the training and verification provided to the user fromthe web-based interactive tool is customized to reflect the content ofthe cartridge, which may be determined based on the cartridgeidentification code.

In one embodiment, a system for competency training and useauthorization for dispensing an agent includes a training deviceconfigured to simulate use of an agent dispensing device. In oneembodiment, the training device is a device separate from theagent-dispensing device. See, e.g., U.S. Pat. Nos. 4,984,158; 5,431,154,which is incorporated herein by reference. In one embodiment, thetraining device is incorporated into the agent-dispensing device. See,e.g., U.S. Patent Application 2008/0147044, which is incorporated hereinby reference. FIG. 4 illustrates further embodiments of agent-dispensingdevice 110 including a training component. Agent-dispensing device 110can optionally include switching circuitry 400 configured to switchagent-dispensing device 110 from a dispensing mode to a training mode.In a dispensing mode, agent-dispensing device 110 is configured todeactivate the locking mechanism in response to a signal upon verifyingthe competency of the user and to respond to a trigger, e.g., pushing ofa button, to activate the controllable agent-dispensing mechanism. Inthe training mode, agent-dispensing device 110 is configured to allowthe user to proceed through all or part of the functional steps neededto administer one or more agents from agent-dispensing device 110without actually administering any agent. In one embodiment,agent-dispensing device 110 in the training mode dispenses a placebo,e.g., a sugar pill, saline, or a puff of air. In one embodiment,agent-dispensing device 110 in the training mode has a retractableinjection needle that does not penetrate the skin while in the trainingmode. In one embodiment, switching from dispensing mode to training modemay include locking the locking mechanism to override any activationsignal until training with the device in training mode has beencompleted.

Agent-dispensing device 110 can optionally include one or more usesensors 410 configured to monitor the use of the agent-dispensing devicein either the dispensing mode or the training mode. For example, usesensor 410 may be used to monitor one or more steps in a trainingprotocol in the training mode. In one embodiment, use sensor 410includes circuitry configured to monitor the proper or improper use ofthe agent-dispensing device while the agent-dispensing device is in atleast one of a dispensing mode or a training mode. For example, usesensor 410 can include circuitry, e.g., wire connector(s), operablyconnected to microprocessor 250 which upon receipt of a signal from usesensor 410 instructs transmission unit 220 to send a signal to acomputing device of the system to provide information to theverification module regarding the monitored one or more steps in thetraining protocol. The verification module of the web-based interactivetool is configured to receive at least one signal from theagent-dispensing device, the at least one signal including informationregarding a proper or improper use of the agent-dispensing deviceacquired from the one or more use sensors. Use sensor(s) 410 can includeat least one of an accelerometer, a timer, an actuator, a pressuresensor, a touch sensor, a temperature sensor, an image capture device,or an inclinometer. Other non-limiting examples of use sensors includeflex sensors, flow sensors, force sensors, gas sensors, gyroscopes,image sensors, moisture sensors, motion sensors, optical sensors,temperature sensors, and vibrations sensors. In one embodiment, the usesensors are small micro electro-mechanical systems (MEMS) sized forinclusion in a handheld agent-dispensing device. In one embodiment, usesensor 410 is an accelerometer, non-limiting examples of which includepiezoelectric, piezoresistive, or capacitance accelerometers, whichconvert mechanical motion into an electrical signal. In one embodiment,use sensor 410 is an inclinometer, non-limiting examples of whichinclude tilt sensors, accelerometers, liquid capacitive, electrolytic,gas bubble in fluid, and pendulum. In one embodiment, use sensor 410 isa pressure or touch sensor for use in monitoring whether or not aparticular component of the agent-dispensing device has been touched,e.g., a button pressed. A timing sensor(s) may be used to monitor whenand in what sequence one or more buttons are pressed. In one embodiment,use sensor 410 can include a camera, charge-coupled device, or otherimage capture device configured to capture images of the user or partsof the user, e.g., a skin surface, while using the agent-dispensingdevice.

FIG. 5 illustrates further embodiments of computing device 150 for usein a system for competency training and use authorization for dispensingan agent. Computing device 150 includes a processing unit 521, a systemmemory 522, and a system bus 523 that couples various system componentsincluding the system memory 522 to the processing unit 521. Processingunit 521 can include a microprocessor, a central processing unit (CPU),a digital signal processor (DSP), an application-specific integratedcircuit (ASIC), a field programmable gate entry (FPGA), or the like, orany combinations thereof, and can include discrete digital or analogcircuit elements or electronics, or combinations thereof. In oneembodiment, the computing device includes one or more ASICs having aplurality of pre-defined logic components. In one embodiment, thecomputing device includes one or more FPGA having a plurality ofprogrammable logic commands.

The system bus 523 may be any of several types of bus structuresincluding a memory bus or memory controller, a peripheral bus, and alocal bus using any of a variety of bus architectures. By way ofexample, and not limitation, such architectures include IndustryStandard Architecture (ISA) bus, Micro Channel Architecture (MCA) bus,Enhanced ISA (EISA) bus, Video Electronics Standards Association (VESA)local bus, and Peripheral Component Interconnect (PCI) bus, also knownas Mezzanine bus.

Computing device 150 includes a user interface, e.g., one or more inputdevices 531 and/or output devices 539 for use by a user to interfacewith the computing device and the web-based interactive tool. The one ormore input devices 531 can be used to enter information into thecomputing device and may be integrated into the computing device or maybe one or more peripheral devices operably connected through a wired orwireless connection to the computing device. Non-limiting examples ofinput devices 531 include a graphical user interface, a display, akeyboard, a keypad, a trackball, a joystick, a touch-screen, a mouse, amicrophone, an image scanner, a digital camera, a webcam, a light pen, abar code reader, a fingerprint scanner, a retinal scanner, a game pad, astylus pen a switch, a dial, or the like.

The user interface may include a character, a key-based, or another userdata input via a keyboard or touch sensitive display. The user interfacemay include using a stylus (not shown). Moreover, the user interface isnot limited to an actual touch-sensitive panel arranged for directlyreceiving input, but may alternatively or in addition respond to anotherinput device such as a microphone. A user may enter commands andinformation into the computing device 150 through user input devices,such as a number of switches and buttons, illustrated as hardwarebuttons 544, connected to the system via a suitable interface 545. Inputdevices 531 may further include a touch-sensitive display with suitableinput detection circuitry, illustrated as a display 532 and screen inputdetector 533. The output circuitry of the touch-sensitive display 532 isconnected to the system bus 523 via a video driver 537. Other inputdevices may include a microphone 534 connected through a suitable audiointerface 535, and a physical hardware keyboard 510. Input device 531may further include a microphone, keyboard, or pointing device, commonlyreferred to as a mouse, trackball, or touch pad. Other input devices mayinclude at least one of a touch sensitive display, joystick, game pad,satellite dish, and scanner.

The user interface includes one or more output devices 539 over whichprocessed information is viewed as output results and may be integratedinto the computing device or may be one or more peripheral devicesoperably connected through a wired or wireless connection to thecomputing device. Output devices may include at least one the display532, or a projector display 536. Non-limiting examples of output devices539 include but are not limited to television screens, computermonitors, liquid crystal displays, audio speakers, audio headphones, andprinters. In one embodiment, the computing device 150 may include atleast one speaker 538 connected through a suitable audio interface 535.The one or more output devices 539 can be used to present text, images,audio and/or video content from the web-based interactive tool. In oneembodiment, the input/output devices include an agent-dispensing deviceoperably connected through a wired or wireless connection to thecomputing device.

In one embodiment, the one or more input/output devices are connected tothe processing unit of the computing device through one or more userinput interface that is coupled to the system bus, but may be connectedby other interface and bus structures, such as a parallel port, gameport, or a universal serial bus (USB). For example, input devices 531 oroutput devices 539, may be connected to the processing unit 521 througha USB port 540 and USB port interface 541, to the system bus 523.Alternatively, the other external input devices 531 and output devices539 may be connected by other interfaces, such as a parallel port, gameport or other port. The computing device 150 may further include or becapable of connecting to a flash card memory (not shown) through anappropriate connection port (not shown). The computing device 150 mayfurther include or be capable of connecting with a network through anetwork port 542 and network interface 543, and through wireless port546 and corresponding wireless interface 547 may be provided tofacilitate communication with other peripheral devices, for example, theagent-dispensing device and/or a training device. It will be appreciatedthat the various components and connections shown are examples and othercomponents and means of establishing communication links may be used.

In one embodiment, image-based applications such as viewers and/ortoolkits (e.g., Insight Segmentation and Registration Toolkit (ITK)),are incorporated for further intake of information. In one embodiment,CAD implementations, image segmentation, or other image analysisalgorithms may allow processing of images received from an image capturedevice.

The system memory includes read-only memory (ROM) 524 and random accessmemory (RAM) 525. A basic input/output system (BIOS) 526, containing thebasic routines that help to transfer information between sub-componentswithin computing device 150, such as during start-up, is stored in theROM 524. A number of program modules may be stored in the ROM 524 or RAM525, including an operating system 527, one or more application programs528, other program modules 529 and program data 530.

Computing device 150 includes computer-readable media products and mayinclude any media that can be accessed by the computing device 150including both volatile and nonvolatile media, removable andnon-removable media. By way of example, and not of limitation,computer-readable media may include non-transitory signal-bearing media.By way of example, and not of limitation, computer-readable media mayinclude computer storage media. By way of further example, and not oflimitation, computer-readable media may include a communication media.

Communication media may typically embody computer-readable instructions,data structures, program modules, or other data in a modulated datasignal such as a carrier wave or other transport mechanism and includeany information delivery media. The term “modulated data signal” means asignal that has one or more of its characteristics set or changed insuch a manner as to encode information in the signal. By way of example,and not limitation, communication media include wired media, such as awired network and a direct-wired connection, and wireless media such asacoustic, radiofrequency, optical, and infrared media.

Computing device 150 may also include other removable/non-removable,volatile/nonvolatile computer storage media products implemented in anymethod or technology for storage of information such ascomputer-readable instructions, data structures, program modules, orother data. For example, such media includes a non-removablenon-volatile memory interface (hard disk interface) 545 reads from andwrites for example to non-removable, non-volatile magnetic media, or aremovable non-volatile memory interface 550 that, for example, iscoupled to a magnetic disk drive 551 that reads from and writes to aremovable, non-volatile magnetic disk 552, or is coupled to an opticaldisk drive 555 that reads from and writes to a removable, non-volatileoptical disk 556, such as a CD ROM. Other removable/nonremovable,volatile/non-volatile computer storage media that can be used in theexample operating environment include, but are not limited to, magnetictape cassettes, magnetic tape, magnetic disk storage, optical diskstorage, memory cards, flash memory cards, DVDs, electrically erasableprogrammable read-only memory (EEPROM), digital video tape, solid stateRAM, and solid state ROM or any other medium which can be used to storethe desired information and which can be accessed by the computingdevice 150. The hard disk drive 557 is typically connected to the systembus 523 through a non-removable memory interface, such as the interface545, and magnetic disk drive 551 and optical disk drive 555 aretypically connected to the system bus 523 by a removable non-volatilememory interface, such as interface 550. In one embodiment, computingdevice 150 includes a computer-readable media drive or memory slotconfigured to accept non-transitory signal-bearing medium (e.g.,computer-readable memory media, computer-readable recording media, orthe like). In one embodiment, a computer storage media may include agroup of computer storage media devices. In one embodiment, a computerstorage media may include an information store. In one embodiment, aninformation store may include a quantum memory, a photonic quantummemory, or atomic quantum memory. Combinations of any of the above mayalso be included within the scope of computer-readable media.

In one embodiment, a program or set of instructions for causing a systemto execute any of the disclosed methods can be stored on, for example, acomputer-readable recording medium (CRMM), a non-transitorysignal-bearing medium, or the like. Non-limiting examples ofsignal-bearing media include a recordable type medium such as magnetictape, floppy disk, a hard disk drive, Compact Disc (CD), a Digital VideoDisk (DVD), Blu-Ray Disc, digital tape, computer memory, or the like, aswell as transmission type medium such as a digital and/or analogcommunication medium (e.g., fiber optic cable, waveguide, wiredcommunications link, wireless communication link). Further non-limitingexamples of signal-bearing media include, but are not limited to,DVD-ROM, DVD-RAM, DVD+RW, DVD-RW, DVD-R, DVD+R, CD-ROM, Super Audio CD,CD-R, CD+R, CD+RW, CD-RW, Video Compact Discs, Super Video Discs, flashmemory, magnetic tape, magneto-optic disk, MINIDISC, non-volatile memorycard, EEPROM, optical disk, optical storage, RAM, ROM, system memory,web server, cloud, or the like.

The drives and their associated computer storage media discussed aboveprovide storage of computer-readable instructions, data structures,program modules, and other data for the computing device 150.

The computing device may operate in a networked environment usinglogical connections to one or more remote computers, such as a remotecomputer 580. The remote computer 580 may be a personal computer, aserver, a router, a network PC, a peer device, or other common networknode, and typically includes many or all of the elements described aboverelative to the computing device 150. The network logical connectionsinclude a local area network (LAN) and a wide area network (WAN), andmay also include other networks such as a personal area network (PAN)(not shown). Such networking environments are commonplace in offices,enterprise-wide computer networks, intranets, and the Internet.

When used in a networking environment, the computing device is connectedto the network 571 through a network interface, such as the networkinterface 570, the modem 572, or the wireless interface 593. The networkmay include a LAN network environment, or a WAN network environment,such as the Internet. In a networked environment, program modulesdepicted relative to the computing device 150, or portions thereof, maybe stored in a remote memory storage device. By way of example, and notlimitation, remote application programs 585 as residing on computermedium 581. It will be appreciated that the network connections shownare examples and other means of establishing communication link betweenthe computers may be used.

In some embodiments, the computing device includes one or more modulesoptionally operable for communication with one or more input/outputcomponents that are configured to relay user output/input. In oneembodiment, a module includes one or more instances of electrical,electromechanical, software-implemented, firmware-implemented, or othercontrol devices. Such devices include one or more instances of memory,computing devices, antennas, power or other supplies, logic modules orother signaling modules, gauges or other such active or passivedetection components, piezoelectric transducers, shape memory elements,micro-electro-mechanical systems (MEMS) elements, or other actuators.

In certain instances, one or more elements of the computing device 150may be deemed not necessary and omitted. In other instances, one or moreother components may be deemed necessary and added to computing device150.

FIG. 6 illustrates further aspects of a system for competency trainingand use authorization for dispensing an agent that includes a web-basedinteractive tool. Web-based interactive tool 160 includes trainingmodule 170 to provide training to a user in proper use of theagent-dispensing device, verification module 180 operable to verify acompetency of the user in the proper use of the agent-dispensing device,and activation module 190 responsive to verification module 180 andoperable to provide an activation signal to a receiver on theagent-dispensing device to deactivate a locking mechanism to allowdispensing of one or more agents from the agent-dispensing device afterverifying the competency of the user.

Training module 170 can include one or more instructions for proper useof the agent-dispensing device, as shown in block 600. The one or moreinstructions may be presented to the user as text, image, audio, and/orvideo content as part of web-based interactive tool 160. The one or moreinstructions can include one or more instructions for proper use of theagent-dispensing device, the one or more agents, and/or one or moreassociated agent-containing cartridges. The one or more instructions caninclude at least one of one or more text-based instructions, one or moreimage-based instructions, one or more audio-based instructions, and/orone or more video-based instructions, as shown in block 610.

In one embodiment, the one or more instructions include one or moretext-based instructions. For example, the one or more instructions canbe provided to the user a series of web-pages associated with theweb-based interactive tool and including text describing proper use ofthe agent-dispensing device. For example, one or more text-basedinstructions may be presented as a word document, a slide presentation,web-based screen shots, or other means or application for displayingtext on a display associated with a computing device.

In one embodiment, the one or more text-based instructions may becombined with one or more image-based instructions and/or audio-basedinstructions. For example, the one or more instructions may be providedto the user as a textual presentation with an audio feed reading and/orembellishing the textual presentation. For example, the one or moreinstructions may be provided to the user as a slide presentation, e.g.,a PowerPoint presentation or a series of photos in Flickr or other imagesharing application, including instructional images with one or moreassociated explanatory audio instructions.

In one embodiment, the one or more instructions are provided to the useras a web-based audio/video presentation with an individual(s), e.g., anactor or a medical professional, demonstrating and/or describing properuse of the agent-dispensing device. For example, the one or moreinstructions may be provided to the user as a video clip that includesinstructions for proper use of the agent-dispensing device. For example,web-based interactive tool 160 may include an embedded audio/videopresentation. For example, the audio/video presentation captured on adigital video camera can be converted to QuickTime, RealMedia, H.264, orOGG using Quick Media Converter (Microsoft, Redmond, Wash.) to allowstreaming video for HTML or HTML5 web integration. For example, theaudio/video presentation may be captured in H.264, Theora OGG, and WebMformats and HTML5 used for embedding. For example, the web-basedinteractive tool may include a link to another website, e.g., YouTube(YouTube, LLC, San Bruno, Calif.), Vimeo (New York, N.Y.), Facebook(Palo Alto, Calif.), Google Video (Mountain View, Calif.), Metacafe(Palo Alto, Calif.), or other video sharing website that hosts theaudio/video instructions. In one embodiment, the audio/videoinstructions may include a series of narrated images using graphicsinterchange format (GIF) animation. In one embodiment, an embeddedaudio/video presentation is accessible to the user on the computingdevice using Windows Media® Player (from Microsoft, Redmond, Wash.) orFlash Player (from Adobe Systems Incorporated, San Jose, Calif.).

In one embodiment, training module 170 of web-based interactive tool 160is entirely an audio presentation describing the proper use of theagent-dispensing device and/or associated agent-containing cartridge. Inthis regard, the audio presentation may be transmitted through one ormore speakers associated with the computing device of the system.Alternatively, the audio presentation may be transmitted through atelephone, through a recording taped on an appropriate medium, e.g., acompact disc, Blu-Ray disc, or cassette tape, through a radiotransmission, through an MP3 audio file, or other transmission form thatallows the user to listen to the presentation.

The one or more instructions can optionally include one or moreinstructions for at least one of operating the agent-dispensing device,dosing the one or more agents from the agent-dispensing device,recognizing one or more side effects of the one or more agents,anticipating interactions of the one or more agents with other agents,storing the agent-dispensing device, or cleaning the agent-dispensingdevice as illustrated in block 620. Other non-limiting examples ofinstructions include instructions for proper handling and care of theagent-dispensing device, e.g., cleaning, changing batteries, and thelike; proper handling and care of replaceable cartridges indicated foruse with the agent-dispensing device, e.g., proper insertion into theagent-dispensing device; storage information (room temperature, chilled,or frozen, depending upon the associated one or more agent eitherincluded in the agent-dispensing device or in one or more associatedreplaceable cartridges); instructions for dosing, e.g., dose amount,timing of doses, schedule of doses, dosing with or without food, dosingwith or without liquid, dosing with other medications, dosing withcertain foods, dosing with certain nutraceuticals or herbal medicines,missed doses, and the like; instructions for monitoring adverse events,e.g., types of possible adverse events associated with a given agent,suggestions for preventing adverse events; instructions for proper useof the agent-dispensing device, e.g., how to hold the device, how toposition on the surface of skin, and the like.

In one embodiment, training module 170 of web-based interactive tool 160includes information from the prescribing information provided to theFood & Drug Administration (FDA) by a pharmaceutical company or otherentity when a prescription medication or over-the-counter medication isbrought to the market, non-limiting examples of which includeindications and usage, dosage and administration, dosage forms andstrength, contraindications, warnings and precautions, black-boxwarnings, adverse reactions, drug interactions, use in specificpopulations (e.g., pregnant or nursing women, elderly, children, maleversus female, hepatic impairment, renal impairment), drug abuse anddependence (in the case of controlled substances), overdosage (e.g.,symptoms and treatment), description of agent, clinical pharmacology(e.g., mechanism of action, pharmacodynamics, pharmacokinetics),nonclinical toxicology (e.g., carcinogenesis, mutagenesis, impairment offertility), how supplied/storage and handling, and patient counselinginformation. As an example, see the prescribing information for morphinesulfate oral solution (from Roxane Laboratories, Inc. Columbus, Ohio),which is incorporated herein by reference.

In one embodiment, training module 170 of web-based interactive tool 160includes text, image, audio, and/or video content including one or moreinstructions for administering one or more agents from theagent-dispensing device to another individual, as illustrated in block630. The one or more agents can include one or more over-the-countermedications, prescription medications, vaccines, antimicrobials,antimalarials, or other agents configured to prevent and/or treat adisease or condition. The text, image, audio, and/or video content caninclude instructions for administering one or more agents from thedispensing device to another individual by inhalation, injection,transdermal, or oral administration. For example, a user, e.g., aparent, home aide, or other caregiver, at a remote distance from amedical clinic or pharmacy may receive the agent-dispensing device andany associated agent-containing cartridges in the mail or by any otherdelivery service. Once the agent-dispensing device is delivered, theuser can access the web-based interactive tool, undergo training andverification, and activate the agent-dispensing device, all withouthaving to travel to a medical clinic or other facility.

In one embodiment, training module 170 of web-based interactive tool 160optionally includes text, image, audio, and/or video content includingone or more instructions for self-administering one or more agents fromthe agent-dispensing device, as illustrated in block 640. The text,image, audio, and/or video content can include instructions forself-administering one or more agents from the dispensing device byself-inhalation, self-injection, transdermal, and oral administration.For example, an individual at a remote distance from a medical clinic orpharmacy may receive the agent-dispensing device and any associatedagent-containing cartridges in the mail or by any other deliveryservice. Once the agent-dispensing device is received, the individualcan access the web-based interactive tool, undergo training andverification, and activate the agent-dispensing device, all withouthaving to travel to a medical clinic or other facility.

FIG. 7 illustrates further aspects of web-based interactive tool 160.Web-based interactive tool includes verification module 180 to verify acompetency of the user in proper use of the agent-dispensing device. Inone embodiment, verification module 180 includes circuitry configured toreceive a user identification input to verify an identity of the user,as shown in block 700. In one embodiment, the user identification inputincludes an identification code that is entered into either thecomputing device and/or the agent-dispensing device and compared with aset of identification codes to verify an identity of the user. In oneembodiment, the user identification input is one or more biometricparameter that can be entered into either the computing device and/orthe agent-dispensing device and compared with a set of biometricparameters of known users to verify an identity of the user. In thisway, the system knows who is being verified during the verificationprocess. In one embodiment, the user identification input may also be anauthorization code that is compared with a set of authorization codesfor authorized users to verify that the user is authorized to use theagent-dispensing device and/or the web-based interactive tool.

In one embodiment, verification includes one or more means for verifyingthat the user is knowledgeable about the use of the agent-dispensingdevice and its contents. In one embodiment, verifying the knowledge ofthe user can include an examination, e.g., a test, e.g., a web-basedmultiple-choose test, either in written or oral form, for which the usermust provide correct responses. In one embodiment, verification module180 can include a text-based questionnaire with one or more text-basedquestions regarding the proper use of the agent-dispensing device, asshown in block 710. For example, the text-based questionnaire isprovided to the user on a display of computing device 150 and the userprovides responses to the text-based questionnaire using one or more ofthe user interfaces associated with computing device 150, e.g., akeyboard or touchpad. In one embodiment, verification module 180 caninclude an audio-based questionnaire with one or more audio-basedquestions regarding the proper use of the agent-dispensing device, asshown in block 720. For example, verification module 150 may include anaudio component able to audibly project questions to the user throughone or more speakers associated with computing device (or theagent-dispensing device itself) and the user provides responses to theaudio-based questions by using one or more user interfaces. In oneembodiment, the user may enter oral responses by speaking into amicrophone associated with computing device 150. In one embodiment, theuser may enter textual responses using a keyboard or touchpad. Thetext-based or audio-based questionnaire can include at least one ofmultiple choice questions, true/false questions, and/or short answerquestions. The text-based or audio-based questionnaire can include oneor more questions related to either the use of the agent-dispensingdevice itself or the one or more agents that will be dispensed from theagent-dispensing device. For example, the text-based or audio-basedquestionnaire can include one or more questions related to the stepsrequired to dispense one or more agents from the device, how to storethe device, how to clean the device, or how to service the device. Forexample, the text-based or audio-based questionnaire can include one ormore questions related to the one or more agents including, but notlimited to, dosing, scheduling, side effects, interactions with otheragents, and the like. The user's responses to the text-based oraudio-based questionnaire are used to assess the competency of the userin proper use of the agent-dispensing device. For example, the user'sresponses to the questionnaire may be compared with a stored set ofresponses and a questionnaire score assigned to the user's responses. Ifthe user's questionnaire score meets or exceeds a pre-definedperformance threshold, the user is deemed competent.

Returning to FIG. 7, web-based interactive tool 160 further includesactivation module 190 responsive to verification module 180 and operableto provide an activation signal to the receiver to deactivate thelocking mechanism to allow dispensing of the one or more agents from theagent-dispensing device after verifying the competency of the user. Inone embodiment, activation module 190 further includes a signalgenerator configured to transmit the activation signal to the receiverto deactivate the locking mechanism to allow dispensing of the one moreagents from the agent-dispensing device after verifying the competencyof the user, as illustrated in block 730. The signal generator caninclude at least one of an electromagnetic signal generator, an opticalsignal generator, an electrical signal generator, a radio signalgenerator, a microwave signal generator, an acoustic signal generator,or a magnetic signal generator. In one embodiment, the signal generatorgenerates a wired signal, e.g., an electrical current along a wire. Inone embodiment, the signal generator generates a wireless signal, e.g.,a radio signal.

Web-based interactive tool 160 optionally includes circuitry configuredto send a report to a caregiver regarding a level of competency of theuser in the proper use of the agent-dispensing device as shown in block740. The report may be sent through either a wired or wireless telephonecommunication, e.g., with an audio recording or a text message. Thereport may be sent from computing device 150 to a caregiver's computingdevice, e.g., via e-mail. In one embodiment, the report can include auser's performance score on one or more of the performance modes of theverification module. For example, the report may include a performancescore on a text-based or audio-based questionnaire. For example, thereport may include a performance score based on analysis of capturedimages. For example, the report may include a performance score based onanalysis of information obtained from use sensors incorporated into theagent-dispensing device. In one embodiment, the report can includeimages of the user using the agent-dispensing device. For example, thereport may include a video stream including a user using and/or trainingwith the agent-dispensing device. In general, a caregiver is interestedin ensuring that the user is capable of administering the one or moreagents either to him or her self or to one or more other individuals.Repeated reports indicating that the user has failed to meet or exceedthe pre-defined performance threshold on multiple tries may indicate aneed for the caregiver to contact the user in person, e.g., by phone ore-mail, to understand what the user is having difficulties with andguide them in improving performance to ensure that the one or moreagents are appropriately dispensed and in a timely fashion.

FIG. 8 shows further aspects of a system for competency training and useauthorization for dispensing an agent. System 100 includesagent-dispensing device 110 for dispensing one or more agents to user195. System 100 further includes computing device 150 configured toprovide web-based interactive tool 160 to user 195. In one embodiment,system 100 includes image capture device 800 operably coupled toverification module 180 of web-based interactive tool 160. Image capturedevice 800 can include, but is not limited to, one or more passive oractive scanners, digital cameras, charge-coupled device (CCD),complementary metal oxide semiconductor (CMOS), infrared sensor, or anyother device or combination thereof suited to capturing an image of user195. In one embodiment, image capture device 800 includes a motion inputsensing device, e.g., a Kinect-like system (from, e.g., Microsoft,Redmond, Wash.). Image capture device 800 is further configured totransmit one or more output signals having information regarding the oneor more captured digital images.

In one embodiment, verification module 180 includes circuitry configuredto receive at least one image of user 195 training with agent-dispensingdevice 110 from image capture device 800 and to compare the received atleast one image with one or more reference images to verify thecompetency of user 195 in proper use of agent-dispensing device 110, asillustrated in block 810. In one embodiment, the one or more referenceimages for use in comparing with the received at least one image of theuser training with the agent-dispensing device are stored inverification module 180 of web-based interactive tool 160. In oneembodiment, the one or more reference images are accessible toverification module 180 from some other source, e.g., a remote databaseaccessed through the Internet.

In one embodiment, verification module 180 of web-based interactive tool160 includes software components or algorithms capable of evaluating theperformance/competency of the user and generates a test score. Ingeneral, the computing device is operable to detect features depicted inthe captured images, e.g., physical registration landmarks, and matchthese features with features in the one or more reference images.Features and the relationships between them may be detected using any ofa number of feature-based methods including, but not limited to,segmentation methods, distance transform, affinely invariantneighborhoods, Harris corner detection, Maximally Stable ExternalRegions, Canny detector, Laplacian of Gaussian, elastic contourextraction, existing edge detection, line intersections, local extremaof wavelet transform, inflection points of curves, and the like.Verification module 180 is further operable to match the featuresdetected in the one or more images with features in the one or morereference images using one or more feature-matching methods,non-limiting examples of which include Euclidean distance matching,invariant moments, nearest neighbor based matching, correlation-likemethods, Fourier methods, mutual information methods, optimizationmethods. Further non-limiting examples include methods using spatialrelations, e.g., graph matching algorithms, methods using invariantdescriptors, and relaxation methods. The following references areincorporated by reference and include descriptions of computationalmethods for image registration: Szeliski Foundations and Trends inComputer Graphics and Vision, Vol. 2, No. 1 (2006) 1-104, Zitova &Flusser Image Vision Computing (2003) 21:977-1000. In one embodiment,verification module 180 includes algorithms for analyzing capturedimages for position of the agent-dispensing device relative to the user,how the agent-dispensing device is being held, how long it takes theuser to dispense the agent from the agent-dispensing device, theposition of the user while dispensing, and the like, and comparing withreference images or other data forms. In one embodiment, verificationmodule 180 includes software applications for assessing images capturedusing a Kinect-like motion sensing input device.

In one embodiment, image capture device 800 is used to generatestreaming video of the user training with the agent-dispensing device.In one embodiment, the streaming video of the user may be assessed by athird party as to the competency of the user in the proper use of theagent-dispensing device. For example, the user may proceed through aseries of steps associated with proper use of the agent-dispensingdevice and/or associated replaceable cartridges. While the user isperforming the steps, live or taped video is being captured for viewingby a third party examiner. In one embodiment, image capture device 800is linked to a video-conferencing capability or voice-over-InternetProtocol system, e.g., SKYPE® (Microsoft, Redmond, Wash.), Google Talk(Google, Mountain View, Calif.), or similar applications, in which theuser is in live video communication with a third party examiner at aremote location who generates a test score based on theperformance/competency of the user.

In one embodiment, correct completion of one or more steps in a trainingprotocol for properly using an agent-dispensing device can be monitoredby one or more use sensors in the agent-dispensing device andcommunicated to the verification module as the user performs the steps.For example, the agent-dispensing device can include circuitryconfigured to record completion of a series of operational steps in thetraining protocol needed to properly use the agent-dispensing device.For example, a series of training protocol steps might include turningon the agent-dispensing device, inserting a cartridge in the properorientation, priming the cartridge, inserting a portion of theagent-dispensing device to an appropriate depth in a body orifice, andpressing a “dispense” button. In one embodiment a signal is sent to theverification module containing information indicating that a particularstep in the training protocol has been completed.

FIG. 9 shows further aspects of a system for competency training and useauthorization for dispensing an agent. System 100 can includeagent-dispensing device 110 for dispensing one or more agents to user195. System 100 further includes computing device 150 configured toprovide web-based interactive tool 160 to user 195. Agent-dispensingdevice 110 can optionally include circuitry configured to transmit atleast one signal 910 from agent-dispensing device 110, the at least onesignal 910 including information regarding the proper or improper use ofagent-dispensing device 110. Signal 910 including information regardingthe proper or improper use of agent-dispensing device 110 can includeeither a wired or wireless transmission. Signal 910 can include anelectrical signal, a radio signal, an electromagnetic signal, anacoustic signal, or an optical signal. Signal 910 can includeinformation obtained from one or more use sensors 410 incorporated intoagent-dispensing device 110 and configured to monitor proper or improperuse of the device. In one embodiment, verification module 180 includescircuitry to receive at least one signal 910 from agent-dispensingdevice 110, the at least one signal including information regarding aproper or improper use of the agent-dispensing device, as illustrated inblock 900. In one embodiment, the circuitry to receive at least onesignal 910 from agent-dispensing device 110 is used to verify thecompetency of user 195 in the proper use of agent-dispensing device 110.In one embodiment, agent-dispensing device 110 includes switchingcircuitry 400 to switch agent-dispensing device 110 from a dispensingmode to a training mode. Agent-dispensing device 110 may further includeone or more use sensors 410 configured to monitor proper or improper useof agent-dispensing device 110 while the device is in at least one ofthe dispensing mode or the training mode. The one or more use sensors410 can include at least one of an accelerometer, a timer, an actuator,a pressure sensor, a touch sensor, a temperature sensor, an imagecapture device, or an inclinometer. For example, use sensor 410 that isan image capture device can be used to capture images of the userperforming one or more operational steps for use of agent-dispensingdevice 110. For example, use sensor 410 that is a pressure sensor can beused to monitor temporal and/or spatial pressing of one or more buttonson agent-dispensing device 110. Output from the one or more use sensors,e.g., one or more signals 910 including information regarding the properor improper use of agent-dispensing device 110, may be transmitted fromtransmission unit 220 back to computing device 150.

FIG. 10 illustrates further aspects of a system for competency trainingand use authorization for dispensing an agent. System 100 includesagent-dispensing device 110 for use in dispensing one or more agents touser 195. System 100 further includes computing device 150 operable toaccess and run web-based interactive tool 160 including training module170, verification module 180, and activation module 190. Verificationmodule 180 can optionally include circuitry configured to generate a setof training results for user 195 upon completion of the trainingprovided by training module 170 and certify user 195 to be competent touse agent-dispensing device 110 if the generated set of training resultsfor user 195 meets or exceeds a pre-defined performance threshold, asshown in block 1000. In one embodiment, the set of training resultsincludes training results from a questionnaire, e.g., the number ofquestions answered correctly on a written or oral test completed usingthe web-based interactive tool. In one embodiment, the set of trainingresults includes training results from image analysis comparing capturedimages with reference images. In one embodiment, the set of trainingresults includes a test score provided by a third party examiner whoobserves the user either through live or taped video feed while the useris performing a series of competency steps or training protocol with theagent-dispensing device. In one embodiment, the set of training resultsis based on feedback provided by the agent-dispensing device, e.g., fromone or more use sensors, while the user is using the device in adispensing and/or training mode.

In one embodiment, the pre-defined performance threshold can include apercentage of correct responses to a text-based or audio-basedquestionnaire. For example, the pre-defined performance threshold may beset at 85%. For example, the pre-defined performance threshold may beset at 100%. The pre-defined performance threshold may include atraining test score of up to 100%, e.g., up to 100% correct answers on aperformance/competency exam. The pre-defined performance threshold mayinclude a training test score of up to 10 on a 1 to 10 performancescale. In one embodiment, the pre-defined performance threshold may beset depending upon the type of agent-dispensing device and/or the one ormore agents to be dispensed and/or the importance of the informationprovided to the user. For example, an agent that has a high likelihoodof adverse reactions or to be addicting may have a higher pre-definedperformance threshold than an agent with lower potential forside-effects or chance of addiction to ensure that the user adequatelyunderstands the risks associated with using or administering the agentprior to activating the agent-dispensing device. In one embodiment, thepre-defined performance threshold may be set based on the anticipateduser, e.g., a medically trained user versus an untrained user. In oneembodiment, the pre-defined performance threshold may be updated in theverification module of the web-based interactive tool to reflect achange. In general, the pre-defined performance threshold can be set bythe maker of the agent-dispensing device and/or cartridges, e.g., apharmaceutical company, the distributer of the agent-dispensing deviceand/or cartridges, e.g., a pharmacy, a caregiver, e.g., a doctor, nurse,aide worker, or other caregiver. The pre-defined performance thresholdmay be set based on the difficulty of using the dispensing device,potential harm caused by inappropriate use of the dispensing device,and/or the critical nature of the prescribing information.

Web-based interactive tool 160 can optionally include circuitryconfigured to send a notification to a caregiver indicating whether ornot the generated set of training results for the user meets or exceedsthe pre-defined performance threshold, as shown in block 1010. Ingeneral, a caregiver is interested in ensuring that the user is capableof administering the one or more agents either to him or her self or toone or more other individuals. Repeated notification indicating that theuser has failed to meet or exceed the pre-defined performance thresholdon multiple tries may indicate a need for the caregiver to contact theuser in person, by phone, or e-mail to understand what the user ishaving difficulties with and guide them in improving performance toensure that the one or more agents are appropriately dispensed and in atimely fashion.

FIG. 11 illustrates further aspects of a system for competency trainingand use authorization for dispensing an agent. System 100 includesagent-dispensing device 110 for use in dispensing one or more agents touser 195. System 100 further includes computing device 150 operable toaccess and run web-based interactive tool 160 including training module170, verification module 180, and activation module 190. Activationmodule 190 is responsive to verification module 180 and operable toprovide an activation signal 145 to a receiver to deactivate a lockingmechanism to allow dispensing of one or more agents fromagent-dispensing device 110 after verifying the competency of user 195.

In one embodiment, activation module 190 includes a stored activationcode 1100. Stored activation code 1100 can be provided to user 195 afterverifying the competency of user 195 and configured to deactivate thelocking mechanism when entered into agent-dispensing device 110 with auser-device interface 280. Stored activation code 1100 can include butis not limited to number code, text code, or alphanumeric code.User-device interface 280 can include, but is not limited to, a display,a speaker, a keypad, buttons, a touchpad, a microphone, or an imagecapture device. For example, user 195 may be provided an alphanumericcode from the activation module upon verification of competency. Theuser then enters the alphanumeric code into agent-dispensing device 110either by entering the alphanumeric code on a keypad or touchpadassociated with agent-dispensing device 110 or reciting the alphanumericcode into a microphone associated with agent-dispensing device 110. Thealphanumeric code is interpreted by circuitry associated with thelocking mechanism, e.g., compared with authorized codes, and if theentered alphanumeric code is an authorized code, the locking mechanismis deactivated to allow dispensing of the one or more agents. In oneembodiment, stored activation code 1100 can include a bar code, QR code,or similar code that is displayed on the display of computing device 150and captured by user-device interface 280, e.g., an image capture deviceor a bar code scanner, associated with agent-dispensing device 110. Inone embodiment, the imaged or scanned code is interpreted by circuitryassociated with the locking mechanism, e.g., compared with authorizedcodes, and if the captured code is an authorized code, the lockingmechanism is deactivated to allow dispensing of the one or more agents.

In one embodiment, activation module 190 includes a signal generator1110. Signal generator 1110 is configured to transmit activation signal145 to the receiver to deactivate the locking mechanism to allowdispensing of the one or more agents from agent-dispensing device 110after verifying the competency of user 195. In one embodiment, signalgenerator 1110 is configured to send a wired transmission, e.g., anelectrical signal, along a wire connecting computing device 150 andagent dispensing device 110. In one embodiment, signal generator 1110 isconfigured to transmit a wireless activation signal directly to theagent-dispensing device after verifying the competency of the user. Thewireless activation signal may be sent from a computing device runningthe web-based interactive tool to agent-dispensing device 110 through awireless Bluetooth transmission. In one embodiment, the wirelessactivation signal to deactivate the locking mechanism is provided from aremote data center either through the computing device or directly tothe agent-dispensing device.

In one embodiment, activation circuitry 190 further includes circuitryconfigured to receive a user identification and to provide auser-specific activation signal as illustrated in block 1120. The useridentification can be received from the verification module in which auser identification input has been used to verify the identity of theuser. In response to the identity of the user, a user-specificactivation signal is transmitted. For example, if the user is identifiedas an authorized user, the signal will be sent. For example, if the useris not identified as an authorized user, the signal may be blockeddespite the user's competency having been verified. In one embodiment,the user-specific activation signal may also be agent specific. Forexample, a first user may have access to agent X and agent Y while asecond user may only have access to agent X and as such, theuser-specific activation signal provided and the locking mechanismdeactivated may reflect these differences in access.

FIG. 12 illustrates further aspects of a system for competency trainingand use authorization for dispensing an agent. System 100 includesagent-dispensing device 110, computing device 150, and web-basedinteractive tool 160 including training module 170, verification module180, and activation module 190. In one embodiment, web-based interactivetool 160 further includes authorization module 1200. Authorizationmodule 1200 includes circuitry configured to authenticate user 195 as anauthorized user of web-based interactive tool 160. In one embodiment,authorization module 1200 includes circuitry to authenticate user 195 asan authorized user of all or part of web-based interactive tool 160. Forexample, a user may be able to access the training module but onlyauthorized users are able to access the verification and activationmodules. In one embodiment, authorization module 1200 is configured todetermine whether or not user 195 is authorized to access web-basedinteractive tool 160 to initiate training, verification, and activationfor use of a particular agent-dispensing device and/or associatedagent-containing cartridge. For example, authorization module 1200 maybe used to allow only an authorized user to use the training andverification modules and ultimately activate agent-dispensing device 110and as such would act as a deterrent to inappropriate and/or illegal useof the agent-dispensing device and/or associated agent-containingcartridge. In one embodiment, authorization module includes circuitry toauthenticate the user as an authorized user of a specificagent-dispensing device 110 and/or associated agent-containingcartridges. For example, authorization module 1200 may be used toprevent an individual who has stolen or inappropriately obtained theagent-dispensing device and/or agent-containing cartridges from beingable to use the device. For example, authorization module 1200 may beused to ensure that only competent, well-trained users are able toactivate the agent-dispensing device and access the associated agents.

In one embodiment, authorization module 1200 includes circuitry toreceive an authorization input from the user, compare the receivedauthorization input from the user with a set of approved authorizationinputs, and unlock access to at least one of the training module,verification module, or activation module if the received authorizationinput from the user satisfies a requirement of at least one of the setof approved authorization inputs, as illustrated in block 1210.

In one embodiment, the authorization input includes an authorizationcode 1220. Authorization code 1220 can be entered into computing device150 to access web-based interactive tool 160. For example, web-basedinteractive tool 160 may include an introductory web-page that includesa space(s) for entering one or more authorization codes to gain accessto other aspects of web-based interactive tool 160. In one embodiment,authorization code 1220 can include a login, e.g., a user ID name andpassword specific for an authorized user. In one embodiment,authorization code 1220 is provided on a smartcard, radiofrequencyidentification (RFID) tag, or other data form that can be “read” bycomputing device 150 or operably connected device to allow access toweb-based interactive tool 160. In one embodiment, authorization code1220 is provided by a physician, a pharmacist, and/or a manufacturer ofthe agent-dispensing device and/or agent-containing cartridge when thedevice is prescribed and/or purchased legally.

In one embodiment, the authorization input includes one or morebiometric parameters 1230. Non-limiting examples of biometric parametersinclude facial recognition, voice recognition, finger prints, retinalscan, blood vessel scans, DNA, handwriting, or other means ofidentifying a specific user. The one or more biometric parametersprovided by a user may be compared with a set of biometric parameters ofauthorized users using one or more comparison algorithms associated withauthorization module 1200

In one embodiment, one or more biometric parameters 1230 can includefacial recognition. For example, the computing device of the system mayinclude or be operably connected to an image capture device, e.g., avideo camera, which captures an image of the user and uses a facialrecognition algorithm to determine whether the image of the user matchesthat of one of a set of authorized users (see, e.g., Phillips et al.,Proceedings of the 7^(th) International conference on Automatic Face andGesture Recognition, FGR06, Southampton, UK, 10-12 Apr. 2006, pp.15-24). Extensive information on facial recognition, associatedalgorithms, and commercial vendors can be accessed athttp://www.face-rec.org/.

In one embodiment, the biometric parameter can include fingerprintrecognition. For example, the computing device of the system may includeor be operably connected to a fingerprint scanning or reader device andassociated recognition software, which scans the fingerprint(s) of theuser and determines whether the fingerprint(s) of the user matches thatof one of a set of authorized users. Any of a number of examples offingerprint readers that connect to a computing device, e.g., a personalcomputer or cellular phone, are commercially available (from, e.g.,Zvetco Biometrics, LLC, Casselberry, Fla.; Microsoft, Redmond, Wash.).In one embodiment, the fingerprint scanner can be associated with theagent-dispensing device. A non-limiting example of a dispensing devicewith fingerprint identification is described in 2011/0166700, which isincorporated herein by reference.

Authorization module 1200 may further include circuitry configured toauthenticate the user as an authorized user of the agent-dispensingdevice as shown in block 1240. In one embodiment, authorization module1200 includes a list of authorized users of a given agent-dispensingdevice and/or agent-containing cartridge. The list of authorized userscan be in the form of a list of names, a list of social securitynumbers, an authorization code, a user-specific biometric parameters, orany other property, number, or code that is specific for a givenindividual. If an unauthorized user is trying to use theagent-dispensing device, authorization module 1200 may further includecircuitry to prevent the activation module from providing the activationsignal or to prevent the agent-dispensing device from dispensing one ormore agents, e.g., transmitting a signal to lock or incapacitate one ormore of the functional components of the agent-dispensing device.

FIG. 13 shows a schematic of a system for competency training and useauthorization for dispensing an agent that includes a training device.System 1300 includes agent-dispensing device 110, computing device 150,and web-based interactive tool 160 accessible to user 195 throughcomputing device 150. Web-based interactive tool includes trainingmodule 170, verification module 180, activation module 190, andoptionally authorization module 1200. System 1300 further includestraining device 1310 which is a stand-alone device separate fromagent-dispensing device 110. Training device 1310 is in communicationwith computing device 150 through a communication link 1320.Communication link 1320 can include at least one of a wired or wirelesscommunication link. Training device 1310 may be used in conjunction withthe training module 170 and/or verification module 180 to instruct user195 in proper use of agent-dispensing device 110 without actuallyadministering an agent to the user or other individual. Training device1310 is meant to simulate all or part of the operational stepsassociated with dispensing one or more agents from agent-dispensingdevice 110 without actually dispensing an agent. For example, thetraining device 1310 may be used to train a user in the use of aninjector device without actually injecting an agent into the skin. Forexample, training device 1310 may be used to train an individual in theuse of an inhaler without actually inhaling an agent into the lung. See,e.g., U.S. Pat. No. 6,358,058, which is incorporated herein byreference. A commercially available example of an inhaler trainerincludes 2Tone Inhaler Trainer from Dynamitech Medical, Bakersfield,Calif.

Training device 1310 may be configured to administer a placebo, e.g.,water, saline, sugar pill, or sugar solution. In one embodiment, atraining device that includes an injection mechanism as the means ofadministering an agent may or may not actually inject a needle orneedles into an individual as part of the training procedure. Forexample, in one embodiment, the training device may be configured toinject saline as part of the training procedure.

In one embodiment, training device 1310 is configured to documentwhether or not the user follows a set of defined steps for using thetraining device and by analogy the agent-dispensing device. For example,the training device may require first loading in a cartridge in anappropriate orientation, arming the training device so that it is readyto dispense the contents of the cartridge, and place the training devicein the vicinity of the appropriate delivery site, e.g., in the mouth forinhalation, on the upper arm or thigh for a single needle injection, onthe abdomen for transdermal administration, and the like.

In one embodiment, use of training device 1310 by user 195 is monitoredelectronically. For example, a series of operational steps may becarried out by a user as part of a training protocol and the completionand accuracy of each step monitored by one or more use sensorsincorporated into training device 1310. For example, training device1310 may include a use sensor, e.g., an accelerometer, which monitorswhether training device 1310 has been shaken appropriately prior to amock administration of an agent. For example, training device 1310 mayinclude a use sensor, e.g., a pressure sensor, which monitors whetherspecific buttons have been pushed in a specific sequence. Non-limitingexamples of use sensors have been described above herein. In oneembodiment, training device 1310 may include circuitry configured totransmit at least one signal from training device 1310 to computingdevice 150, the at least one signal including information regarding aproper or improper use of the training device as garnered from the oneor more use sensors. Training device 1310 is in wired or wirelesscommunication link 1320 with at least one of computing device 150 oragent-dispensing device 110. For example, information regarding thecompletion and accuracy of each step can be transmitted from atransmission unit incorporated in training device 1310 to computingdevice 150 to provide an indication as to whether the user has learnedthe appropriate steps and/or technique for using the training device andby analogy the actual agent-dispensing device. Non-limiting aspects of atransmission unit have been described above herein.

In one embodiment, verification module 180 of web-based interactive tool160 includes circuitry configured to receive at least one signal fromtraining device 1310, the at least one signal including informationregarding a proper or improper use of training device 1310. Verificationmodule 180 can further include circuitry configured to generate a set oftraining results for the user based on input from training device 1310and certify that the user is competent to use the agent-dispensingdevice if the generated set of training results for the user meets orexceeds a pre-defined performance threshold.

In one embodiment, use of training device 1310 is monitored visually. Inone embodiment, system 1300 may include an image capture device (notshown) associated with training device 1310 and/or computing device 110for use in visually monitoring a user while using training device 1310.For example, a user may be filmed using an image capture deviceassociated with the training device or the computing device whiletraining with the training device and the video images compared withstored reference images or streamed back to a third party observer at aremote location for evaluation of the user's competency with thetraining device. In one embodiment, verification module 180 includescircuitry configured to receive at least one image of the user 195training with training device 1310 from an image capture device and tocompare the received at least one image with one or more referenceimages to verify the competency of user 195 in proper use of trainingdevice 1310 and by extension, competency in proper use ofagent-dispensing device 110.

In one embodiment, training device 1310 includes a device that simulatesa body or tissue target site and may be used in conjunction withagent-dispensing device in at least one of a dispensing mode or atraining mode. For example, training device 1310 may include aninjection simulator that simulates anatomical features of an injectionsite on a part of a subject's body, e.g., on a part of a subject's arm.See, e.g., various injection simulators available from Simulution®,Burnsville, Minn. For example, training device 1310 may include asimulator that simulates an orifice into which dispensing device isintended to be insert, for example mouth, nostrils, or portions of theurogenital tract. See, e.g., various patient and medical simulators fromSimulaids, Coalville Leicestershire, UK.

FIG. 14 shows a schematic of a system for competency training and useauthorization for dispensing an agent. System 1400 includes device 1410that includes agent-dispensing device 110 and computing device 150 in asingle unit. System 1400 further includes web-based interactive tool 160accessible to user 195 through computing device 150. Web-basedinteractive tool 160 includes training module 170, verification module180, activation module 190, and optionally authorization module 1200. Inone embodiment, device 1410 including combined agent-dispensing device110 and computing device 150 is a handheld device. For example, device1410 may include a mobile device, e.g., a mobile phone, which stores anddispenses one or more agents. In one embodiment, device 1410 is asmartphone device that includes one or more reservoirs containing one ormore agents. The one or more reservoirs can be incorporated directlyinto the smartphone device or attachable as an accessory to a standardsmartphone device. An example of a mobile phone with the capacity tostore an agent, e.g., a medication, is described in U.S. PatentApplication Publication 2007/0184812, which is incorporated herein byreference. For example, device 1410 may include a dedicated hand-helddevice, designed and operated solely for the purpose of dispensing oneor more agents after training and verification. In one embodiment,device 1410 including combined agent-dispensing device 110 and computingdevice 150 is a desk-top device. Device 1410 is configured to dispenseone or more agents for preventing and/or treating a disease orcondition. In general, 1410 including agent-dispensing device 110 andcomputing device 150 is fully capable of accessing web-based interactivetool 160, e.g., through the Internet, and progressing through trainingmodule 170, verification module 180, and activation module 190. Onceuser 195 has completed the training module and the verification modulehas verified that the user is competent to use device 1410, theactivation module provides a signal to deactivate a locking mechanism toallow dispensing of one or more agents from agent-dispensing device 110.Web-based interactive tool 160 further includes circuitry configured tosend a notification to a caregiver indicating whether or not a generatedset of training results for the user meets or exceeds a pre-definedperformance threshold, as shown in block 1010.

Further non-limiting aspects of device 1410 includes at least one of acontrollable dispensing mechanism, a locking mechanism, a transmissionunit including a receiver and an antenna, a power source, a user-deviceinterface, a transmission unit including a receiver and an antenna, amicroprocessor, at least one reservoir, user identification circuitry,switching circuitry, and one or more use sensors. The one or morecomponents of agent-dispensing device 110 and the one or more componentsof computing device 150 of device 1410 are operably connected to oneanother through circuitry, e.g., electrical circuitry. Computing device150 of device 1410 is operable to run web-based interactive tool 160.The controllable agent-dispensing mechanism of agent-dispensing device110 is operably connected to the at least one reservoir and isconfigured to controllably release material in response to an activationsignal. In one embodiment, the at least one reservoir is anagent-containing cartridge inserted into a receptacle associated withdevice 1410. In one embodiment, the at least one reservoir is anagent-containing cartridge attached to the periphery of a standardsmartphone, e.g., through a USB port.

In one embodiment, circuitry for training and verification of competencyof a user prior to authorizing dispensing of one or more agents isentirely self-contained within an agent-dispensing device. FIG. 15 showsa schematic of an embodiment of an agent-dispensing device.Agent-dispensing device 1500 includes housing 1510. Housing 1510includes at least one reservoir 1520 configured to store one or moreagents for treating and/or preventing a disease and/or condition.Housing 1510 further includes controllable agent-dispensing mechanism1530 in communication with the at least one reservoir 1520 and lockingmechanism 1540 coupled to controllable agent-dispensing device 1530.Housing 1510 further includes microprocessor 1550 including circuitryconfigured to operate agent-dispensing device 1500 in a dispensing modeor a training mode and one or more use sensors 1560 configured tomonitor at least one operational step for use of agent-dispensing device1500 in the training mode. Agent-dispensing device 1500 further includestraining circuitry 1570 configured to train the user in the at least oneoperational step for use of agent dispensing device 1500 and to assign avalue for each of the monitored at least one operational step for use ofagent-dispensing device 1500 in the training mode, verificationcircuitry 1580 configured to determine if the assigned value for each ofthe monitored at least one operational step for use of agent-dispensingdevice 1500 in the training mode meets or exceeds a pre-definedperformance threshold, and activation circuitry 1590 responsive toverification circuitry 1580 and configured to deactivate lockingmechanism 1540 to allow dispensing of the one or more agents fromreservoir 1520 if the assigned value for each of the monitored at leastone operational step for use of agent-dispensing device 1500 in thetraining mode meets or exceeds the pre-defined performance threshold.

Agent-dispensing device 1500 is configured to controllably dispense oneor more agents for preventing and/or treating a disease or medicalcondition upon deactivating a locking mechanism of agent-dispensingdevice 1500 in response to verification that the user is qualified touse agent-dispensing device 1500. Non-limiting examples of diseasesand/or conditions include but are not limited to cardiovasculardisorders, renal disorders, metabolic disorders, neurodegenerativedisorders, psychological disorders, neuromuscular and pain disorders,gastrointestinal disorders, gynecological and urological disorders,cancer, inflammation, autoimmune disorders, dermatological disorders,microbial infections and the like.

Agent-dispensing device 1500 is a self-contained device containing allof the components needed for activation and controllable release of oneor more therapeutic or preventative agents after verification of thecompetency of the user. In one embodiment, agent-dispensing device 1500includes housing 1510 that is sized for easy use with one or two hands,e.g., a hand-held housing. Agent-dispensing device 1500 can include oneor more of an injection device, an inhalation device, a solid formdispensing device, a liquid form dispensing device, a gas formdispensing device, or a transdermal dispensing device. In oneembodiment, agent-dispensing device 1500 is configured for intranasaladministration of a therapeutic or preventative agent. In oneembodiment, agent-dispensing device 1500 is configured for vaginal orrectal administration of a therapeutic or preventative agent. Ingeneral, agent-dispensing device 1500 can be configured to administerone or more agents to one or more of an ear, a nostril, a mouth, athroat, a lung, skin, urethra, vagina, or rectum. In one embodiment,agent-dispensing device 1500 can be a smart pill intended for oralingestion or rectal insertion. In one embodiment, agent-dispensingdevice 1500 is implantable. In one embodiment, agent-dispensing device1500 is sized for placement into either the vascular or lymphaticsystem.

In one embodiment, agent-dispensing device 1500 includes an inhalerdevice. For example, agent-dispensing device 1500 may be an inhaler,e.g., a metered dose inhaler, for use in administering an inhaled agent,e.g., a corticosteroid and/or beta-adrenoceptor agonist for treatingasthma or chronic obstructive pulmonary disease.

In one embodiment, agent-dispensing device 1500 includes an injectordevice. For example, agent-dispensing device 1500 may be an injectorwith a needleless injection system, e.g., a jet-injection system, foruse in administering a vaccine. An example of a jet injection system isdescribed in Kim & Prausnitz, Curr. Top. Microbiol. Immunol. (2012)351:77-112, which is incorporated herein by reference.

In one embodiment, agent-dispensing device 1500 includes an oral drugdispenser. For example, agent-dispensing device 1500 may hold one ormore orally administered agents, e.g., a pill or oral solution, that arecontrollably released from agent-dispensing device 1500 after training,verification, and activation.

In one embodiment, agent-dispensing device 1500 includes a transdermaldrug dispenser. For example, agent-dispensing device 1500 may be atransdermal patch, e.g., an iontophoretic patch, which controllablyreleases an agent, e.g., an analgesic agent for mitigating pain, acrossthe dermal layer. An example of a controllable iontophoretic transdermalpatch is described in Kasha et al., Drug Discov. Ther. (2012) 6:256-262,which is incorporated herein by reference.

Agent-dispensing device 1500 includes at least one reservoir 1520including one or more agents for treating and/or preventing one or moredisease and/or condition. In one embodiment, reservoir 1520 is anintegral part of agent-dispensing device 1500 and configured to storeand dispense one or more agents. The one or more agents stored inreservoir 1520 can be in any of a number of physical forms, non-limitingexamples of which include gaseous form, solid form, liquid or gel form.In one embodiment, the one or more agents include solid form agents,e.g., one or more of a pill, tablet, small particles, powder, ordissolvable film.

In one embodiment, reservoir 1520 can include a single storage spacefrom which one or more agents are controllably released. For example,reservoir 1520 can include a hollow space within agent-dispensing device1500 configured to store and dispense one or more tablets. For example,reservoir 1520 can include a fluid reservoir configured to store anddispense multiple doses of an injectable agent, e.g., insulin. In oneembodiment, reservoir 1520 can include a separate storage space for eachagent to be stored and dispensed. For example, reservoir 1520 caninclude two storage spaces, a first storage space containing agent X anda second storage space containing agent Y. In one embodiment, reservoir1520 can include a plurality of storage spaces from which each dose ofone or more agents is dispensed. For example, reservoir 1520 may includea series of storage spaces, each storage space covered by a removableseal. In one embodiment, reservoir 1520 can be configured to berefilled, e.g., having a resealable cover that can be removed by a useror other individual, e.g., a pharmacist, to refill reservoir 1520 withone or more agents. Refilling reservoir 1520 with one or more agentsthat are different from one or more agents previously stored anddispensed from the agent-dispensing device may trigger an update to whatis provided to the user in training circuitry 1570 and verificationcircuitry 1580 to reflect the new one or more agents intended for usewith the agent-dispensing device.

Reservoir 1520 of agent-dispensing device 1500 is configured for storingand dispensing one or more agents for preventing and/or treating adisease or condition. In one embodiment, the one or more agents includeone or more therapeutic agents. Non-limiting examples of therapeuticagents for use in an agent-dispensing device have been described aboveherein. In one embodiment, the one or more agents include one or morepreventative agents, e.g., vaccines, non-limiting examples of which havebeen described above herein. It is anticipated that other vaccinescurrently in development for human immunodeficiency virus (HIV) andcancer, for example, will be of use in agent-dispensing device describedherein. In one embodiment, the one or more agents include one or moreantidotes used to counteract the effects of a poison. Non-limitingexamples of antidotes have been described above herein. In oneembodiment, the one or more agents include one or more controlledsubstances, a comprehensive list of which are described in theControlled Substances Act (CSA) of the Comprehensive Drug AbusePrevention and Control Act of 1970 and codified under Title 21 Code ofFederal Regulations. An updated and complete list of the schedules forcontrolled substances is published annually in Title 21 Code of FederalRegulations (C.F.R.) §§1308.11 through 1308.15 and can be accessed athttp://www.deadiversion.usdoj.gov/21cfr/cfr/2108cfrt.htm.

Agent-dispensing device 1500 includes controllable agent-dispensingmechanism 1530. Controllable agent-dispensing mechanism 1530 can includeany of a number of means for dispensing a therapeutic or preventativeagent for treating and/or preventing a disease and/or condition.Non-limiting examples of controllable agent-dispensing mechanismsinclude one or more of an inhalation mechanism, an injection mechanism,a nebulization mechanism, an intranasal mechanism, a rectal mechanism,an intravaginal mechanism, a transdermal delivery mechanism, apill-dispensing mechanism, a solid form dispensing mechanism, a liquidform dispensing mechanism, or a gas form dispensing mechanism.Non-limiting examples of controllable agent-dispensing mechanisms havebeen described above herein.

Agent-dispensing device 1500 further includes locking mechanism 1540coupled to controllable agent-dispensing mechanism 1530 and capable ofbeing activated or deactivated through activation circuitry 1590.Locking mechanism 1540 can include any of a number of means forpreventing actuation of the controllable agent-dispensing mechanism 1530or release of agent from agent-dispensing device 1500. Non-limitingexamples of locking mechanisms include camshaft-driven lockingmechanism, spring loaded bar, bar/slide, retractable pin, latch, or hookwhich may be electrically, optically, or magnetically actuated inresponse to an activation signal.

Agent-dispensing device 1500 includes microprocessor 1550 includingcircuitry configured to operate the agent-dispensing device in adispensing mode or a training mode. Microprocessor 1550 further includescircuitry configured to control one or more functions ofagent-dispensing device 1500 including controlling communication betweenvarious components of agent-dispensing device 1500, and controllingcommunication between external entities and agent-dispensing device1500. In one embodiment, microprocessor 1550 is operably linked to atleast one of controllable agent-dispensing mechanism 1530, lockingmechanism 1540, one or more use sensors 1560, training circuitry 1570,verification circuitry 1580, and/or activation circuitry 1590. In oneembodiment, microprocessor 1550 is connected to one or more othercomponents of agent-dispensing device 1500 through one or more wiredconnection, e.g., electrical connections. In one embodiment,microprocessor 1550 is connected to one or more other components ofagent-dispensing device 1500 through one or more wireless connection,e.g., optical connections or electromagnetic connection. In oneembodiment, microprocessor 1550 includes central processing unit (CPU)of agent-dispensing device 1500. In one embodiment, microprocessor 1550includes logic, memory and control circuitry configured to control oneor more functions of one or more components of agent-dispensing device1500, e.g., controlling one or more functions of one of controllableagent-dispensing mechanism 1530, locking mechanism 1540, one or more usesensors 1560, training circuitry 1570, verification circuitry 1580,and/or activation circuitry 1590. In one embodiment, microprocessor 1550may be part of a microcontroller including a microprocessor, memory,clock, and I/O control. In one embodiment, microprocessor 1550 includesembedded software configured to control one or more functions ofagent-dispensing device 1500.

Agent-dispensing device 1500 includes one or more use sensors 1560. Usesensors 1560 are configured to monitor one or more steps in a trainingprotocol associated with training a user to properly useagent-dispensing device. Use sensors 1560 are configured to monitor atleast one of a series of button, keypad, or other touches, movement ofthe device, timing and sequence of steps performed in the trainingprotocol, and the like. Use sensors 1360 can include one or more of anaccelerometer, a timer, an actuator, a pressure sensor, a touch sensor,a temperature sensor, an image capture device, or an inclinometer,non-limiting examples of which have been described above herein.

Agent-dispensing device 1500 includes training circuitry 1570 configuredto train a user in at least one operational step for use ofagent-dispensing device 1500 and to assign a value for each of themonitored at least one operational step for use of the agent-dispensingdevice in a training mode. In one embodiment, training circuitryincludes one or more instructions for proper use of agent-dispensingdevice 1500 including the at least one operational step for use ofagent-dispensing device. The one or more instructions are accessible tothe user through a user-device interface associated withagent-dispensing device 1500. Training circuitry 1570 includes circuitryfor providing at least one of one or more text-based instructions, oneor more image-based instructions, one or more audio-based instructions,and/or video-based instructions provided to the user through auser-device interface. In one embodiment, the one or more instructionsare entirely contained within training circuitry 1570. In oneembodiment, at least one of the one or more instructions is accessed bytraining circuitry 1570 from an external source, e.g., a web-site on theInternet. In one embodiment, the output from training circuitry 1570,e.g., the training instructions, is dependent upon the one or moreagents stored in the at least one reservoir 1520. In one embodiment, thetraining instructions, e.g., one or more instructions for the at leastone operational step for use of agent-dispensing device 1500, areupdateable, reflecting changes in how agent-dispensing device 1500should be used or changes in the one or more agents being dispensed fromthe device.

Training circuitry 1570 can provide one or more instructions regardingat least one operational step for use of agent-dispensing device 1560.Non-limiting examples of operational steps include specific buttons topush or switches to flip, a sequencing of buttons to push or switches toflip, a timing between pushing two or more buttons or flipping two ormore switches, priming the device, e.g., shaking or pumping the device,cooling the device, heating the device, or moving the device inproximity to a body part, e.g., the mouth or the skin.

Training circuitry 1570 can also provide one or more instructions for atleast one of operating agent-dispensing device 1500, dosing the one ormore agents from agent-dispensing device 1500, recognizing one or moreside effects of the one or more agents, anticipating interactions of theone or more agents with other agents, storing agent-dispensing device1500, or cleaning agent-dispensing device 1500. Other non-limitingexamples of instructions include instructions for proper handling andcare of agent-dispensing device 1500, e.g., cleaning, changingbatteries, and the like; proper handling and care of replaceablecartridges indicated for use with agent-dispensing device 1500, e.g.,proper insertion into agent-dispensing device 1500; storage information(room temperature, chilled, or frozen, depending upon the associated oneor more agent either included in agent-dispensing device 1500 or in oneor more associated replaceable cartridges); instructions for dosing,e.g., dose amount, timing of doses, schedule of doses, dosing with orwithout food, dosing with or without liquid, dosing with othermedications, dosing with certain foods, dosing with certainnutraceuticals or herbal medicines, missed doses, and the like;instructions for monitoring adverse events, e.g., types of possibleadverse events associated with a given agent, suggestions for preventingadverse events; instructions for proper use of agent-dispensing device1500, e.g., how to hold the device, how to position on the surface ofskin, and the like. In one embodiment, training circuitry 1570 includesprescribing information provided to the United States Food & DrugAdministration (FDA) by a pharmaceutical company or other entitybringing a prescription medication or over-the-counter medication to themarket, non-limiting examples of which have been described above herein.

In one embodiment, training circuitry 1570 is configured to train a userto administer one or more agents from agent-dispensing device 1500 toanother individual. For example, training circuitry 1570 can includeinstructions for at least one operational step to administer one or moreagents from agent-dispensing device 1500 to another individual byinhalation, injection, transdermal, or oral administration. For example,a user, e.g., a parent, home aide, or other caregiver, at a remotedistance from a medical clinic or pharmacy may receive theagent-dispensing device and any associated agent-containing cartridgesin the mail or by any other delivery service. Once the agent-dispensingdevice is delivered, the user can access training on the device andundergo training and verification, and activate the agent-dispensingdevice, all without having to travel to a medical clinic or otherfacility.

In one embodiment, training circuitry 1570 is configured to train a userto self-administer one or more agents from agent-dispensing device 1500.For example, training circuitry 1570 can include instructions for atleast one operational step for self-administering one or more agentsfrom agent-dispensing device 1500 by self-inhalation, self-injection,transdermal, and oral administration. For example, an individual at aremote distance from a medical clinic or pharmacy may receive theagent-dispensing device and any associated agent-containing cartridgesin the mail or by any other delivery service. Once the agent-dispensingdevice is received, the individual can access training on the device andundergo training and verification, and activate the agent-dispensingdevice.

Training circuitry 1570 is also configured to receive information fromone or more use sensors 1560 incorporated into agent-dispensing device1500. In one embodiment, a user trains with agent-dispensing device 1500in accordance with the training instructions and at least one of theoperational steps are monitored with one or more use sensors 1560. Basedon feedback from use sensors 1560, training circuitry 1570 is configuredto assign a value to each of the monitored at least one operationalsteps. For example, one or more pressure sensors can be used to monitortemporal and/or spatial pushing of one or more buttons onagent-dispensing device 1500. For example, an accelerometer and a timercan be used to determine if agent-dispensing device 1500 has beenadequately shaken or primed prior to use. For example, an image capturedevice associated with agent-dispensing device 1500 can be used todetermine whether the appropriate body part was accessed with thedevice, e.g., the appropriate portion of skin for an injection orplacement of a transdermal patch. In one embodiment, training circuitry1570 includes one or more algorithms for comparing one or more capturedimages, e.g., images of the user using the agent-dispensing device, withone or more reference images stored in a memory of the agent-dispensingdevice and assigns a value for each of the monitored at least oneoperational step based on the comparison. In one embodiment, trainingcircuitry 1570 is configured to capture video of a user training withagent-dispensing device 1500 and to transmit the captured video anexternal third party examiner, e.g., via video-conferencing, whotransmits back a value for each of the monitored at least oneoperational step for use of the agent-dispensing device, e.g., aperformance score. In one embodiment, training circuitry 1570 mayinclude a text-based or audio-based questionnaire for testing the user'sknowledge regarding the use of the agent-dispensing device or the one ormore agents and assigns a value based on the user's responses to thequestionnaire, e.g., the number of correct answers. A user-deviceinterface, e.g., a display, touchpad, speaker, or microphone, associatedwith the agent-dispensing device may be used to provide user responsesto the questionnaire.

In one embodiment, correct completion of one or more steps in a trainingprotocol for properly using an agent-dispensing device is monitored byone or more use sensors in the agent-dispensing device and communicatedto the training circuitry as the user performs the steps. For example,the agent-dispensing device can include circuitry configured to recordcompletion of a series of steps in the training protocol needed toproperly use the agent-dispensing device. For example, a series of stepsin a training protocol might include turning on the agent-dispensingdevice, inserting a cartridge in the proper orientation, priming thecartridge, inserting a portion of the agent-dispensing device to anappropriate depth in a body orifice, and pressing a “dispense” button.In one embodiment a signal is sent to the verification module containinginformation regarding an assigned value for each of the monitored atleast one operations step for use of the agent-dispensing device.

Verification circuitry 1580 is configured to determine if the assignedvalue for each of the monitored at least one operational step for use ofthe agent-dispensing device in the training mode meets or exceeds apre-defined performance threshold. For example, each of the monitored atleast one operational step for use of the agent-dispensing device mayhave a score range, e.g., a score range from 0-5, with the trainingcircuitry configured to assign a value from the score range for each ofthe monitored at least one operation step performed by the user in thetraining mode. In one embodiment, verification circuitry 1580 includescircuitry configured to receive a set of assigned values for each of themonitored at least one operational step for use of the agent-dispensingdevice from the training circuitry, and certify the user to be competentto use the agent-dispensing device if each of the set of assigned valuesfor each of the monitored at least one operational step for use of theagent-dispensing device meets or exceeds the pre-defined performancethreshold. For example, verification circuitry 1580 may determine ifeach value meets or exceeds the pre-defined performance threshold foreach step, and if each value meets or exceeds the pre-definedperformance threshold, the verification module verifies the competencyof the user. For example, a first step may have an assigned value of 3which meets a pre-defined performance threshold of 3, while a secondstep may have an assigned value of 2 which does not meet a pre-definedperformance threshold of 3, and therefore the user's competency cannotbe verified. In one embodiment, verification circuitry 1580 includecircuitry configured to receive a set of assigned values for each of themonitored at least one operational step for use of the agent-dispensingdevice from the training circuitry, and certify the user to be competentto use the agent-dispensing device if the sum of the set of assignedvalues for each of the monitored at least one operational step for useof the agent-dispensing device meets or exceeds the pre-definedperformance threshold. For example, verification circuitry 1580 maydetermine if the sum of each of the values meets or exceeds thepre-defined performance threshold for the sum of the steps, and if thesum of each of the values meets or exceeds the pre-defined performancethreshold, the verification module verifies the competency of the user.

In one embodiment, verification circuitry 1580 is configured to receivea set of assigned values for each of the monitored at least oneoperational step for use of the agent-dispensing device from thetraining circuitry. In one embodiment, the set of assigned valuesincludes feedback provided by the use sensors while the user trains withthe agent-dispensing device in a training mode. In one embodiment, theset of assigned values includes assigned values from a questionnaire,e.g., the number of questions answered correctly on a written or oraltest provided by the training circuitry. In one embodiment, the set ofassigned values includes results from image analysis comparing capturedimages with reference images. In one embodiment, the set of assignedvalues includes a performance score provided by a third party examinerwho observes the user either through live or taped video feed while theuser is performing at least one operational step for use of theagent-dispensing device.

In one embodiment, the pre-defined performance threshold may be set at85%. In one embodiment, the pre-defined performance threshold may be setat 100%. For example, the pre-defined performance threshold may includean assigned value of up to 10 on a 1 to 10 performance scale. Thepre-defined performance threshold may include an assigned value of up to100%, e.g., up to 100% correctly performed operational steps or answerson a performance/competency exam. In one embodiment, the pre-definedperformance threshold may be set depending upon the type ofagent-dispensing device and/or the one or more agents to be dispensedand/or the importance of the information provided to the user. Forexample, an agent that has a high likelihood of adverse reactions or tobe addicting may have a higher pre-defined performance threshold than anagent with lower potential for side-effects or chance of addiction toensure that the user adequately understands the risks associated withusing or administering the agent prior to activating theagent-dispensing device. In one embodiment, the pre-defined performancethreshold may be set based on the anticipated user, e.g., a medicallytrained user versus an untrained user. In one embodiment, thepre-defined performance threshold may be updated in the verificationcircuitry. In general, the pre-defined performance threshold can be setby the maker of the agent-dispensing device and/or cartridges, e.g., apharmaceutical company, the distributer of the agent-dispensing deviceand/or cartridges, e.g., a pharmacy, a caregiver, e.g., a doctor, nurse,aide worker, or other caregiver. The pre-defined performance thresholdmay be set based on the difficulty of using the agent-dispensing device,potential harm caused by inappropriate use of the dispensing deviceand/or the critical nature of the prescribing information. In oneembodiment, the pre-defined performance threshold is stored in a memorycomponent of the agent-dispensing device. In one embodiment, thepre-defined performance threshold is updatable.

Agent-dispensing device 1500 further includes activation circuitry 1590responsive to verification circuitry 1580 and configured to deactivatelocking mechanism 1540 to allow dispensing of the one or more agents ifthe assigned value for each of the monitored at least one operationalstep for use of agent-dispensing device 1500 in the training mode meetsor exceeds the pre-defined performance threshold. Activation circuitry1590 is configured to provide an activation signal to deactivate thelocking mechanism to allow dispensing of the one or more agents from theagent-dispensing device after verifying the competency of the user. Theactivation signal can include at least one of an electromagnetic signal,an optical signal, an electrical signal, a radio signal, a microwavesignal, an acoustic signal, or a magnetic signal.

FIG. 16 illustrates further aspects of an agent-dispensing device suchas shown in FIG. 15. Reservoir 1520 of agent-dispensing device 1500 caninclude one or more outlets 1600. One or more outlets 1600 areconfigured to allow one or more agents to be dispensed from reservoir1520 and can include, but are not limited to, one or more of a valve, aseptum, a gate, or a removable seal. For example, one or more outlets1600 can include a valve that is actuated in response to the activationsignal. In one embodiment, the one or more outlets 1600 can be used forrefilling reservoir with one or more agents. For example, one or moreoutlets 1600 that includes a lockable screw top can be opened, one ormore agents placed in reservoir 1520, and the lockable screw topreclosed.

Microprocessor 1550 of agent-dispensing device 1500 can includeswitching circuitry 1610. Switching circuitry 1610 is configured toswitch operation of agent-dispensing device 1500 between a dispensingmode and a training mode. In the dispensing mode, all of the componentsnecessary for dispensing one or more agents from the device are readyfor use once verification and activation have occurred. In the trainingmode, only a subset of the components necessary for dispensing one ormore agents from the device are ready for use, e.g., the componentsnecessary to train the user in proper use of the agent-dispensingdevice. For example, various buttons or plungers may be actuatable butare otherwise disconnected from the controllable agent-dispensingmechanism such that no agent is dispensed. For example, a needlecomponent of an injection device may be retracted in a training mode.For example, a second reservoir containing a placebo, e.g., water orsaline, may be accessed in training mode while a first reservoircontaining one or more therapeutic or preventative agents may only beaccessed in dispensing mode. Switching from training to dispensing modecan be part of activation mediated by the activation circuitry of thedevice.

Agent-dispensing device 1500 may further include user-device interface1620 for interfacing with the user. User-device interface 1620 may beoperably linked to training circuitry 1570, verification circuitry 1580,and/or activation circuitry 1590, and can include, but is not limitedto, display 1621, speaker 1622, keypad 1623, buttons 1624, touchpad1625, microphone 1626, and/or image capture device 1625. In oneembodiment, training circuitry 1570 includes at least one of text,images, audio, or video training instructions regarding the at least oneoperational step for use of agent-dispensing device 1500, the traininginstructions accessible to the user through user-device interface 1620.

In one embodiment, agent-dispensing device 1500 further includes atransmission unit 1630 including an antenna. Transmission unit 1630including an antenna is configured to transmit and receive wirelesssignals. For example, transmission unit 1630 may be configured toreceive wireless signals containing information with updates to trainingcircuitry 1570, verification circuitry 1580, and/or activation circuitry1590. In one embodiment, updates are sent to the agent-dispensing devicedepending upon one or more conditions, non-limiting examples of whichinclude the one or more agents being dispensed, the location ofdispensing, or the identity of the user trying to use the device. Forexample, transmission unit 1630 may be connected to circuitry configuredto prepare and transmit information regarding the user's trainingprogress in the form of a report. The report may be transmitted to acaregiver, e.g., a nurse, doctor, or pharmacist to provide informationon whether or not the user has been able to train him or herselfadequately to enable activation of the agent dispensing device. Thereport may be transmitted to the manufacturer and/or supplier of theagent-dispensing device to provide information regarding ease of use ofthe product and/or technical difficulties with the product. Non-limitingaspects of a transmission unit have been described above herein.

In one embodiment, transmission unit 1630 may be configured forbi-directional communication link with an external source. Thebi-directional communication link can include one or more of apoint-to-point link, a broadcast link, a multipoint link, apoint-to-point link, a private link, and/or a public link. Thebi-directional communication link can be selected from, but not limitedto, a telephone line, an intranet, the Internet, a satellite, amicrowave radio relay, a laser waveform, or a global positioning systemlink. Non-limiting examples of dispensing devices with communicationlinks are described in U.S. Patent Application 2011/0166700, and U.S.Patent Application 2001/0022279, which are incorporated herein byreference.

Agent-dispensing device 1500 can further include authorization circuitry1640 configured to authenticate the user as an authorized user of theagent dispensing device. Authorization circuitry 1640 is operably linkedto microprocessor 1550 and configured to authenticate the user as anauthorized user of the agent-dispensing device by comparing a user inputwith a set of authorized user inputs. User input can be entered usinguser-device interface 1620 operably connected to authorization circuitry1640. In one embodiment, the user input may include entering anauthorization code using user-device interface 1620, the enteredauthorization code compared with a set of authorized authorizationcodes. For example, the user input may include entering an alphanumericcode which is compared to a set of stored authorized alphanumeric codes.In one embodiment, the user input may include one or more biometricparameters, e.g., a fingerprint, a retinal scan, facial recognition, orother biometric input, the entered biometric input compared with storedbiometric input for authorized users. For example, agent-dispensingdevice may include a user-device interface that is a fingerprint scanneron which a potential user must place a finger, e.g., index finger, forcomparison with a set of stored authorized fingerprints. In oneembodiment, activation permission is tied to a specific user of theagent-dispensing device. For example, the activation circuitry mayinclude circuitry configured to receive a user identification, e.g., anauthorization code and/or one or more biometric parameters, and toprovide a user-specific activation signal. In one embodiment, activationcircuitry 1590 is responsive to authorization circuitry 1640 andconfigured to deactivate the locking mechanism only for an authorizeduser of the agent-dispensing device. For example, even if a user is ableto go through the training and verification, that user may not be anauthorized user, in which case activation may be denied, preventing theone or more agents from being dispensed.

Agent-dispensing device 1500 includes power source 1650. Power source1650 is operably connected to one or more components of agent-dispensingdevice including, but not limited to, reservoir 1520, controllableagent-dispensing mechanism 1530, locking mechanism 1540, microprocessor1550, use sensor 1560, training circuitry 1570, verification circuitry1580, activation circuitry 1590, outlet 1600, switching circuitry 1610,user-device interface 1620, transmission unit 1630, and authorizationcircuitry 1640. Non-limiting examples of power sources have beendescribed above herein.

In one embodiment, the at least one reservoir of agent-dispensing device1500 includes at least one replaceable cartridge configured to bereceived by a docking site associated with the housing of theagent-dispensing device. FIG. 17 illustrates further aspects of anagent-dispensing device such as that depicted in FIG. 15 including atleast one replaceable cartridge. Agent-dispensing device 1500 mayoptionally include housing 1700 which includes docking site 1710configured to allow docking of one or more replaceable cartridge 1720 toagent-dispensing device 1500. In one embodiment, docking site 1710 caninclude one or more receptacles or openings defined by one or more wallsor surfaces of housing 1700 into which one or more replaceable cartridge1720 is able to be inserted. For example, docking site 1710 may includea cylindrical space configured to accommodate insertion of a cylindricalreplaceable cartridge 1720. For example, docking site 1710 may include arectangular space configured to accommodate insertion of a rectangularreplaceable cartridge 1720. In one embodiment, docking site 1710 caninclude a male/female connector, e.g., a male portion of housing 1700configured to insert or snap into a female portion of replaceablecartridge 1720. In one embodiment, the male/female connection is made atone or more outlets 1730 in the replaceable cartridge through which oneor more agents contained in the cartridge will eventually be dispensed.The one or more outlets 1730 may include a seal that is broken uponforming the male/female connection. In one embodiment, docking site 1710includes a groove into which an appropriately shaped portion ofreplaceable cartridge 1720 is able to slide and lock into. In oneembodiment, docking site 1710 can include at least one magnetic surfaceconfigured to magnetically interact with at least one magnetized surfaceof replaceable cartridge 1720. In one embodiment, a portion of dockingsite 1710, e.g., a sharp beveled tube forming an enclosed fluid channel,may puncture an outlet into replaceable cartridge 1720 upon insertingreplaceable cartridge 1720 into docking site 1710. For example,replaceable cartridge 1720 can be a vial including a septum, the septumof the vial punctured by needle-like structure associated with dockingsite 1710.

Agent-dispensing device 1500 can accommodate one or more cartridges1720. Any given replaceable cartridge 1720 is configured for storing anddispensing one or more agents for preventing and/or treating a diseaseor condition, non-limiting examples of which have been described aboveherein. In one embodiment, the at least one agent contained inreplaceable cartridge 1720 is released directly to the user from one ormore controllable outlets 1730 associated with replaceable cartridge1720. In one embodiment, the at least one agent contained in replaceablecartridge 1720 is released indirectly to the user throughagent-dispensing device 1500. For example, the at least one agent may bereleased into agent-dispensing device 1500 from replaceable cartridge1720 and subsequently controllable agent-dispensing mechanism 1530 isactivated to release the at least one agent from agent-dispensing device1500. In this way, the cartridge itself does not need a controllabledispensing mechanism. For example, insertion of replaceable cartridge1720 into docking site 1710 may penetrate a septum associated withreplaceable cartridge 1720. However, it is intended that no agent isreleased until agent-dispensing device 1500 is activated, e.g., afterlocking mechanism 1540 of controllable agent-dispensing mechanism 1530is deactivated and unlocked following training and verification ofcompetency of the user. Replaceable cartridge 1720 is primed to releasematerial, e.g., a therapeutic or preventative agent, and may evenrelease material into a holding reservoir or chamber associated withagent-dispensing device 1500 from which the material is ultimatelyreleased to the user in response to deactivation of the lockingmechanism. In one embodiment, agent-dispensing device 1500 may includean actuator that is activated by the activation signal and triggersopening of an outlet on the cartridge.

Replaceable cartridge 1720 can include any of a number of packagingforms appropriate for storing and dispensing agents for treating and/orpreventing a disease or condition. Non-limiting examples of packagingforms include one or more of a pressurized canister, glass vial withseptum, blister package, other packaging with removable seals, aluminumcan or bottle, antistatic bag, ampule, sachet, collapsible tube,flexible pouch, bottle, box, plastic bottle, pouch, or microchip. Theone or more agents stored in replaceable cartridge 1720 can be in any ofa number of physical forms, non-limiting examples of which includegaseous form, solid form, liquid or gel form. In one embodiment, the oneor more agents include solid form agents, e.g., one or more of a pill,tablet, small particles, powder, or dissolvable film.

In one embodiment, replaceable cartridge 1720 can include a singlestorage space from which one or more agents are controllably released.For example, replaceable cartridge 1720 can include a replaceablecanister configured to store and dispense multiple metered doses of aninhalant, e.g., the asthma medication salbuterol or the flu vaccineFluMist®. For example, replaceable cartridge 1720 can include areplaceable vial configured to store and dispense multiple doses of aninjectable agent, e.g., insulin. In one embodiment, replaceablecartridge 1720 includes a separate storage space for each agent to bestored and dispensed. For example, replaceable cartridge 1720 mayinclude two storage spaces, a first storage space containing agent X anda second storage space containing agent Y. In one embodiment, dockingsite 1710 is configured to accept a first and second replaceablecartridge, the first cartridge configured to store and dispense at leastone first agent and the second cartridge configured to store anddispense at least one second agent. In one embodiment, replaceablecartridge 1720 can include a plurality of storage spaces from which eachdose of one or more agents is dispensed. For example, replaceablecartridge 1720 may include a series of storage spaces, each storagespace covered by a removable seal. Replacing cartridge 1720 with a newcartridge containing one or more agents that differ from the one or moreagents in the replaced cartridge 1720 may trigger an updates to thetraining and verification circuitry to reflect the new one or moreagents intended for use with the agent-dispensing device.

In one embodiment, agent-dispensing device 1500 includes cartridgeidentification circuitry 1740 configured to read a cartridgeidentification code, e.g., a radiofrequency tag or bar code, associatedwith the inserted replaceable cartridge 1720. The cartridgeidentification code can be used to identify the one or more agentscontained in the cartridge and dosing information. In one embodiment,the output of the training circuitry, e.g., the type of informationand/or instructions provided to the user, is dependent upon the at leastone cartridge configured for storing and dispensing the one or moreagents. For example, agent-dispensing device 1500 may be capable ofaccepting different types of cartridges containing different types ofagents. As such, the training and verification provided to the user iscustomized to reflect the content of the cartridge, which may bedetermined based on the cartridge identification code. In oneembodiment, agent-dispensing device includes circuitry to scan datacarried on the replaceable cartridge. For example, agent-dispensingdevice may include a scanner capable of reading a bar code carried onthe replaceable cartridge.

FIG. 18 illustrates a method of verifying user competency of anagent-dispensing device. The method includes providing a web-basedinteractive tool to a user through a computing device, the web-basedinteractive tool including stored text, images, audio, and/or video, anda training module to provide training to the user in proper use of theagent-dispensing device, a verification module to verify a competency ofthe user in the proper use of the agent-dispensing device, and anactivation module responsive to the verification module and operable toprovide an activation signal to deactivate a locking mechanism of theagent-dispensing device at block 1800; training the user in the properuse of the agent-dispensing device using the training module of theweb-based interactive tool at block 1810; verifying a competency of theuser in the proper use of the agent-dispensing device using theverification module of the web-based interactive tool at block 1820; andactivating the agent-dispensing device with the activation module of theweb-based interactive tool by providing the activation signal todeactivate the locking mechanism to allow dispensing of one or moreagents from the agent-dispensing device after verifying the competencyof the user in the proper use of the agent-dispensing device at block1830.

FIG. 19 illustrates further aspects of a method such as that shown inFIG. 18. In one embodiment, the method includes authenticating the useras an authorized user of the web-based interactive tool using anauthorization module of the web-based interactive tool, theauthorization module including circuitry configured to authenticate theuser as an authorized of the web-based interactive tool, and authorizingaccess to one or more of the training module, the verification module,or the activation module of the web-based interactive tool asillustrated in block 1900. In one embodiment, the authorization modulelimits the use of at least a portion of the web-based interactive toolto only an authorized user. For example, a user may only be able toaccess the web-based interactive tool by signing into a website with auser name/ID and password. For example, a user may be able to access thetraining module of the web-based interactive tool but must be verifiedas an authorized user prior to verifying performance and deactivatingthe locking mechanism to allow dispensing of one or more agents from theagent-dispensing device. In one embodiment, authorization to accessportions of the web-based interactive tool is dependent upon the user'sauthorization to use a specific agent-dispensing device and/or agent.

In one embodiment, the method includes at block 1910 receiving anauthorization input from the user with a user interface coupled to thecomputing device; comparing the received authorization input from theuser with a set of approved authorization inputs stored in theauthorization module; and unlocking access to at least one of thetraining module, the verification module, or the activation module ifthe authorization input from the user satisfies a requirement of atleast one of the set of approved authorization inputs. In oneembodiment, authorization module includes a list of authorized users ofa given agent-dispensing device and/or agent-containing cartridge. Thelist of authorized users can be in the form of a list of names, a listof social security numbers, an authorization code, a user-specificbiometric parameters, or any other property, number, or code that isspecific for a given individual. If an unauthorized user is trying touse the agent-dispensing device by accessing activation through theweb-based interactive tool, the authorization module may further includecircuitry to prevent the activation module from providing the activationsignal or to prevent the agent-dispensing device from dispensing one ormore agents, e.g., transmitting a signal to lock or incapacitate one ormore of the functional components of the agent-dispensing device.

In one embodiment, the authorization input can include an authorizationcode as shown in block 1920. In one embodiment, the authorization codecan include an alphanumeric login and/or password specific for the user.For example, the user may receive a login and/or password for authorizedentry into web-based interactive tool from a physician, pharmacist,manufacturer, or other relevant entity, the login and/or passwordentered into the computing device using a user interface component. Inone embodiment, the authorization code is provided on a smartcard,radiofrequency identification (RFID) tag, or other data form that can be“read” by the computing device or operably connected device to allowaccess to web-based interactive tool.

In one embodiment, the authorization input optionally includes one ormore of a biometric parameter as shown in block 1930. In one embodiment,the one or more of a biometric parameter include one or more of facialrecognition, voice recognition, fingerprint recognition, retinal scan,or DNA scan, as shown in block 1940. Other non-limiting examples ofbiometric parameters include blood vessel scans, handwriting, or othermeans of identifying a specific user. The one or more biometricparameters provided by a user may be compared with a set of biometricparameters of authorized users using one or more comparison algorithmsassociated with the authorization module.

In one embodiment, it may be necessary to provide authorization input,e.g., an authorization code or biometric parameter, directly to theagent-dispensing device through a user-device interface prior to usingthe agent-dispensing device. For example, the agent-dispensing devicemay include user identification circuitry that accepts authorizationinput and compares user input with a set of authorized users of theagent-dispensing device prior to unlocking any functions of the device.

FIG. 20 illustrates further aspects of a method such as that shown inFIG. 18. The method includes providing a web-based interactive tool to auser through a computing device, as shown in block 1800. The methodincludes providing the web-based interactive tool to a computing deviceaccessible to the user through a desktop computer, a laptop computer, atablet computing device, a personal electronic device, or a dedicatedcomputing device accessible to the user as illustrated in block 2000.Other non-limiting examples of computing devices for use in the methodhave been described above herein. In one embodiment, the method includesproviding the web-based interactive tool to a computing deviceincorporated into the agent-dispensing device.

In one embodiment, the method includes providing the web-basedinteractive tool to the user through the computing device via theInternet, as shown in block 2010. In one embodiment, the method includesproviding the web-based interactive tool to the user through thecomputing device in communication with a remote server, as shown inblock 2020. For example, the web-based interactive tool can be providedto a laptop computer situated in a user's residence using an Internetconnection. For example, the web-based interactive tool can be providedto a user's smartphone using a broadband/Internet provider. In oneembodiment, the method includes providing the web-based interactive toolfrom one or more servers located in a location remote from the user. Inone embodiment, the method includes providing the web-based interactivetool from a mainframe computer located in a location remote from theuser. The remote server can be part of a computer network, web service,cloud-based infrastructure, or the like. In one embodiment, the methodincludes providing the web-based interactive tool from agovernment-affiliated location, e.g., the Food & Drug Administration(FDA), the Center for Disease Control (CDC), the World HealthOrganization, or a local/state/national public health department. In oneembodiment, the method can include providing the web-based interactivetool from the source of the agent-dispensing device and/or associatedcartridges, e.g., from a pharmaceutical company, a pharmacy or pharmacychain, or a hospital or clinic. In one embodiment, the method includesproviding the web-based interactive tool from an international site,e.g., in a country distinct from the country in which theagent-dispensing device is used. For example, a remote server could belocated in an industrialized/developed country, e.g., the United Statesor Europe and accessible to a user in a developing country, e.g., a WestAfrican country, through a satellite communications link. For example,the method could include remotely training and verifying the competencyof a user, e.g., an aide worker, located in a developing country andactivating the agent dispensing device for dispensing a vaccine or othertherapeutic agent in that developing country.

FIG. 21 illustrates further aspects of a method such as that shown inFIG. 18. The method includes training the user in the proper use of theagent dispensing device using the training module of the web-basedinteractive tool. In one embodiment, the method includes training theuser with one or more of text-based training, image-based training,audio-based training, or video-based training associated with thetraining module, as shown in block 2100. For example, the method caninclude training the user using text, image, audio, and/or video contentcontained with the training module or accessible to the training module.The method includes training the user in the proper use and care of theagent-dispensing device and in the proper use of the one or more agentsdispensed from the device and can include, but is not limited to,training in proper handling and care of the dispensing device, e.g.,cleaning, changing batteries, and the like; handling and care ofcartridges indicated for use with the agent-dispensing device, e.g.,proper insertion and storing; training in proper dosing, e.g., timingand dosing restrictions; training in monitoring adverse events; andtraining in proper use of the agent-dispensing device, e.g., how to holdthe device and positioning of device relative to skin or other bodypart. In one embodiment, the method may include training the user byproviding prescribing information for the one or more agents.

In one embodiment, the method includes using the training module of theweb-based interactive tool in combination with a training device asshown in block 2110. Examples and uses of a training device incombination with a web-based interactive tool have been described aboveherein. The training device can be a separate entity or can beincorporated into the drug dispensing device, as shown in block 2120 andin FIG. 4. Optionally, the training device dispenses a placebo dosageform, e.g., water, saline, a sugar pill, or a sugar solution. Ingeneral, using the training device in combination with the web-basedinteractive tool allows the user to train on a device nearly identicalto the agent-dispensing device without actually administering (orwasting) the active agent.

In one embodiment, the method includes training the user using thetraining module of the web-based interactive tool to self-administer theone or more agents from the agent-dispensing device as shown in block2130. For example, the web-based interactive tool can include one ormore instructions for self-administering one or more agents configuredto prevent and/or treat a disease or condition. The method can includetraining the user to use the dispensing device for self-inhalation,self-injection, transdermal, and oral administration. For example, anindividual in a remote location can receive the agent-dispensing deviceand any associated agent-containing cartridges through a deliveryservice, access the web-based interactive tool, undergo training andverification, and activate the agent-dispensing device, all withouthaving to travel to a clinic or other medical facility.

In one embodiment, the method includes training the user using thetraining module of the web-based interactive tool to administer the oneor more agents from the agent-dispensing device to at least one otherindividual, as shown in block 2140. For example, the web-basedinteractive tool can include one or more instructions for administeringone or more agents from the agent-dispensing device to anotherindividual. The method can include training the user to administer oneor more agents from the agent-dispensing device to another individual byinhalation, injection, transdermal, or oral administration. For example,the user may be a family member, a friend, or other caregiver of anindividual for whom the agent-dispensing device and/or associatedcartridges has been prescribed. In some embodiments, the caregiver maybe a user who is tending to one specific individual, for example ahospice nurse. In some embodiments, the caregiver may be a user who iscaring for a number of individuals in a household or community. Forexample, the caregiver may be a physician, nurse, EMT or other caregiverworking in a remote and/or isolated village, e.g., in rural Alaska or infield station in Antarctica. For example, the caregiver may be an aideworker working in a remote and isolated village in a developing country.For example, the caregiver may be a local individual who otherwise hasno medical experience, but under emergency circumstances is called uponto administer one or more agents, e.g., a vaccine or an antidote, toother members of a community. For example, a user, e.g., a parent, homeaide, or other caregiver, in a remote location may receive theagent-dispensing device and any associated cartridges through a deliveryservice, access the web-based interactive tool, undergo training andverification, and activate the agent-dispensing device, all withouthaving to travel to a medical clinic or other facility.

FIG. 22 illustrates further aspects of a method such as that shown inFIG. 18. The method includes verifying the competency of the user in theproper use of the agent-dispensing device using the verification moduleof the web-based interactive tool as shown in block 1820. Verifying thecompetency of the user may include generating a test score, e.g., apercentage of questions answered correctly in either a written or oralexam or a performance score based on analysis of captured images.Verifying the competency of the user can include an automatic assessmentbased on signals sent from the agent-dispensing device or an associatedtraining device while the user trains with the device. In oneembodiment, verifying the competency of the user may be correlated withachieving a test score that meets or exceeds a pre-defined performancethreshold, e.g., 85% or higher. In one embodiment, verifying thecompetency of the user may include interacting with a third partyobserver via a communications link.

In one embodiment, verifying a competency of the user is performed usingthe verification module only after training has been completed, e.g.,after the user has viewed and/or listened to the entirety of thetraining instructions included in the training module. For example, theweb-based interactive tool can be constructed such that the user cannotaccess the verification module until the training module has been fullyviewed. In one embodiment, a user who has completed the training in thepast may choose to by-pass the training module and proceed directly tothe verification module. For example, the web-based interactive tool canbe constructed to include “memory” that a particular user has alreadycompleted training and offer direct access to the verification module,thus by-passing the requirement to go through the components of thetraining module prior to accessing the verification module.

In one embodiment, verifying the competency of the user in the properuse of the agent-dispensing device includes administering aquestionnaire to the user using the computing device, assigning aquestionnaire score based on the user's answers to the questionnaire,and determining if the assigned questionnaire score meets or exceeds apre-defined questionnaire score threshold stored in the verificationmodule, as illustrated in block 2200. In one embodiment, thequestionnaire is provided to the user in a text form as various screenson the display of the computing device, the user providing answersthrough a user interface of the computing device, e.g., a keyboard ortouchpad. In one embodiment, the questionnaire is provided to the userin an audio form, the user providing answers either using a keyboard ortouchpad or by providing verbal responses through a microphone coupledto the computing device. The user's responses to the text-based oraudio-based questionnaire are used to assess the competency of the userin proper use of the agent-dispensing device. For example, the user'sresponses to the questionnaire may be compared with a stored set ofresponses and a questionnaire score assigned to the user's responses. Ifthe user's assigned questionnaire score meets or exceeds a pre-definedquestionnaire score, the user is deemed competent.

In one embodiment, verifying the competency of the user in the properuse of the agent-dispensing device includes capturing one or more imagesof the user with an image capture device coupled to the computing devicewhile the user is training the with agent-dispensing device, assigning aperformance score based on comparing the captured one or more imageswith a set of reference images in the verification module, anddetermining if the assigned performance score meets or exceeds apre-defined performance score threshold stored in the verificationmodule, as shown in block 2210. In one embodiment, the verificationmodule of the web-based interactive tool includes software components oralgorithms capable of evaluating the performance/competency of the userby comparing with a stored set of reference images and generates a testscore. Non-limiting examples of algorithms for analyzing images havebeen described above herein.

In one embodiment, the method includes verifying the competency of theuser in the proper use of the agent-dispensing device throughvideo-conferencing. For example, the competency of the user is verifiedby having the user proceed through a series of steps associated withproper use of the agent-dispensing device and/or associated cartridgeswhile being videotaped with an image capture device. In one embodiment,the live or taped video is viewed by a third party examiner whogenerates a test score based on the performance/competency of the user.In one embodiment, the user is in live video communication with a thirdparty examiner using a video conferencing tool, e.g., SKYPE® (Microsoft,Redmond, Wash.). In one embodiment, the user is taped performing one ormore steps, the taped session sent to a third party examiner, and aperformance test score provided to the user.

In one embodiment, verifying the competency of the user in the properuse of the agent-dispensing device includes activating a training modeon the agent-dispensing device, monitoring at least one operational stepfor use of the agent-dispensing device in the training mode with atleast one use sensor on the agent-dispensing device, assigning a valuefor each of the monitored at least one operational step, transmitting asignal from the agent-dispensing device to the computing device withinformation regarding the assigned value for each of the monitored atleast one operational step, and determining if the assigned value foreach of the monitored at least one operational step meets or exceed apre-defined value threshold stored in the verification module, asillustrated in block 2220. In one embodiment, activating a training modeon the agent-dispensing device includes switching from a dispensing modeto a training mode using switching circuitry associated with theagent-dispensing device. Monitoring at least one operational step foruse of the agent-dispensing device in the training mode with at leastone use sensor on the agent-dispensing device includes monitoring the atleast one operation step with at least one of an accelerometer, a timer,an actuator, a pressure sensor, a touch sensor, inclinometer,temperature sensor, or image capture device. Other non-limiting examplesof use sensors include flex sensors, flow sensors, force sensors, gassensors, gyroscopes, moisture sensors, motion sensors, optical sensors,and vibrations sensors.

FIG. 23 illustrates further aspects of a method such as that shown inFIG. 18. The method of verifying the competency of the user in theproper use of the agent-dispensing device using the verification moduleof the web-based interactive tool further optionally includes generatinga set of training results for the user upon completion of the trainingmodule, and certifying the user is competent to use the agent-dispensingdevice if the set of training results for the user meets or exceeds apre-defined performance threshold, as illustrated in block 2300. In oneembodiment, the set of training results includes answers to one or morequestions regarding the proper use of the agent-dispensing device, asillustrated in block 2310. The answers can be text or oral responses toone or more text or audio-based questionnaires provided to the user fromthe verification module. In one embodiment, the set of training resultsincludes one or more images of the user performing one or moreoperational steps with the agent-dispensing device, as illustrated inblock 2320. In one embodiment, the set of training results includes oneor more values transmitted to the computing device from one or more usesensors associated with the agent-dispensing device, the one or more usesensors monitoring at least one operational step performed by the userwith the agent-dispensing device, as illustrated in block 2330. Ingeneral, the set of training results is compared with a set of storedtest scores, images, or operational steps associated with or accessibleby the verification module of the web-based interactive tool.

In one embodiment, the pre-defined performance threshold may include atraining test score of up to 100%, e.g., up to 100% correct answers on aperformance/competency exam. The pre-defined performance threshold mayinclude a training test score of up to 10 on a 1 to 10 performancescale. In general, the pre-defined performance threshold can be set bythe maker of the agent-dispensing device and/or cartridges, e.g., apharmaceutical company, the distributer of the dispensing device and/orcartridges, e.g., a pharmacy, a caregiver, e.g., a doctor, nurse, aideworker, or other caregiver. The pre-defined performance threshold may beset based on the difficulty of using the agent-dispensing device,potential harm caused by inappropriate use of the dispensing device,and/or the critical nature of the prescribing information. For example,when using a particularly dangerous agent with a potential for harmfulside-effects and/or abuse, the pre-defined performance threshold may beset higher to ensure that the user is very competent at using theagent-dispensing device and/or associated cartridges prior to activatingthe agent-dispensing device.

Returning to FIG. 23, in one embodiment, the method includesre-verifying a competency of the user in the proper use of theagent-dispensing device after a time interval, as shown in block 2340.In one embodiment, re-verification may be required prior to using theagent-dispensing device if the device or an associated agent-containingcartridge has not been used by the user for a long time or is usedinfrequently. For example, re-verification may be warranted if the userhas not used the agent-dispensing device and/or the associated agent inmore than a year. In one embodiment, the method further includesre-verifying a competency of the user in the proper use of theagent-dispensing device after an event, as illustrated in block 2350.For example, re-verification may be warranted in response to changes inFDA regulations, changes to the prescribing information for the agent,e.g., inclusion of a black-box warning, upgrades to the agent-dispensingdevice, and/or upgrades/changes to the web-based interactive tool, e.g.,upgrades/changes to the training module and/or verification module, orchanges in the pre-defined performance threshold.

FIG. 24 illustrates aspects of a method for training and verifying acompetency of a user prior to activating an agent-dispensing device. Themethod includes one or more steps implemented with a web-basedinteractive tool running on a computing device. The method includesprovide a user with access to the web-based interactive tool at block2400. In one embodiment, provide a user with access can includeproviding the user with a URL for accessing the web-based interactivetool through the Internet. Once the user has entered the first page,e.g., a home page, of the web-based interactive tool, query the user forauthorization input at block 2405. In one embodiment, the authorizationinput includes an authorization code, e.g., an alphanumeric code. In oneembodiment, the authorization input includes a biometric input, e.g., ascan of one or more of the user's fingers with a fingerprint scannerlinked to the computing device. In block 2410, compare userauthorization input with stored authorization input. In block 2415,decide if the user is an authorized user. If yes, provide trainingcontent to user at block 2420. If no, return to block 2405 to re-queryuser for authorization input. At block 2425, determine if all trainingcontent has been viewed by the user. If yes provide a questionnaire atblock 2430 posing questions regarding the training content. If no,return to block 2420 to continue to provide training content to theuser. At block 2435, compare user responses to the questionnaire withstored answers in the verification module. At block 2440, generate ascore based on the comparison of the user responses and the storedanswers. In block 2445, decide if the score meets or exceeds acompetency threshold, e.g., a pre-defined performance threshold. If yes,send activation signal to agent-dispensing device at block 2450. If no,return to block 2320 to provide training content to the user.

FIG. 25 illustrates aspects of a method for training and verifying acompetency of a user prior to activating an agent-dispensing device. Themethod includes one or more steps implemented with a web-basedinteractive tool running on a computing device. The method includesprovide a user with access to the web-based interactive tool at block2500. In one embodiment, provide a user with access can includeproviding the user with a URL for accessing the web-based interactivetool through the Internet. Once the user has entered the first page,e.g., a home page, of the web-based interactive tool, query the user forauthorization input at block 2505. In one embodiment, the authorizationinput includes an authorization code, e.g., an alphanumeric code. In oneembodiment, the authorization input includes a biometric input, e.g., ascan of one or more of the user's fingers with a fingerprint scannerlinked to the computing device. In block 2510, compare userauthorization input with stored authorization input. In block 2515,decide if the user is an authorized user. If yes, provide trainingcontent to the user at block 2520. If no, return to block 2505 tore-query the user for authorization input. At block 2525, determine ifall training content has been viewed by the user. If yes, capture one ormore images of the user training with the agent-dispensing device atblock 2530. If no, return to block 2520 to continue to provide trainingcontent to user. At block 2535, compare the images of the user trainingwith the agent-dispensing device with a set of reference images. In oneembodiment, the reference images include still photos showing proper useof the agent-dispensing device. In one embodiment, the reference imagesinclude video showing proper use of the agent-dispensing device. Thecomparison is made using any of a number of image comparison algorithms,examples of which have been described above herein. At block 2540,generate a score based on the image comparison. At block 2545, decide ifthe score meets or exceeds a competency threshold, e.g., a pre-definedperformance threshold. If yes, provide an activation signal toagent-dispensing device to deactivate a locking mechanism to allowcontrolled dispensing of one or more agents at block 2550. If no, returnto block 2520 and provide additional training content to user.

FIG. 26 illustrates aspects of a method of verifying user competencyimplemented with circuitry in agent-dispensing device 2600. The methodincludes authenticating the user as an authorized user of theagent-dispensing device, wherein the agent-dispensing device includes atleast one of authorization circuitry, training circuitry, one or moreuse sensors, verification circuitry, or activation circuitry in block2610, training the user in at least one operational step for user of theagent-dispensing device with one or more training instructions includedin the training circuitry in block 2620, monitoring the user'sperformance of the at least one operational step for use of theagent-dispensing device with the one or more use sensors incorporated inblock 2630, assigning a value to each of the monitored at least oneoperational step for use of the agent-dispensing device performed by theuser in block 2640; verifying with the verification circuitry if theassigned value for each of the monitored at least one operational stepfor use of the agent-dispensing device meets or exceeds a pre-definedperformance threshold in block 2650, and activating the agent-dispensingdevice with the activation circuitry responsive to the verificationcircuitry to allow dispensing of one or more agents from theagent-dispensing device if the assigned value for each of the monitoredat least one operational step for use of the agent-dispensing devicemeets or exceeds the pre-defined performance threshold in block 2660.

In one embodiment, the method of FIG. 26 further includes authenticatingthe user as an authorized user of the agent-dispensing device byreceiving an authorization input from the user with a user-deviceinterface associated with the agent-dispensing device; comparing thereceived authorization input from the user with a set of approvedauthorization inputs; and unlocking access to at least one of thetraining circuitry, the verification circuitry, or the activationcircuitry if the authorization input from the user satisfies arequirement of at least one of the set of approved authorization inputs.The authorization input can include at least one of an authorizationcode or a biometric parameter, examples of which have been describedabove herein.

In one embodiment, the method of FIG. 26 further includes training theuser in the at least one operational step for use of theagent-dispensing device with one or more instructions included in thetraining circuitry includes providing the user with one or more of text,image, audio, or video including one or more instructions for the atleast one operational step for use of the agent-dispensing device. Theone or more instructions can include one or more operational stepsincluding specific buttons to push or switches to flip, a sequence ofbuttons to push or switches to flip, a timing between pushing two ormore buttons or flipping two or more switches, priming the device, e.g.,shaking or pumping the device, cooling the device, heating the device,or moving the device in proximity to a body part, e.g., the mouth or theskin.

In one embodiment, the method of FIG. 26 further includes activating theagent-dispensing device by sending an activation signal to deactivate alocking mechanism of a controllable agent-dispensing mechanism of theagent-dispensing device. In one embodiment, the activation signaloriginates from the activation circuitry of the agent-dispensing device,the activation circuitry being responsive to the verification circuitry.

FIG. 27 illustrates aspects of a computer-implemented method running oncomputing device 2700 for authorizing use of an agent-dispensing devicefollowing competency training. The method includes connecting a user toa web-based interactive tool through a bi-directional communicationnetwork link at block 2710, receiving authorization informationassociated with the user through the bi-directional communication linkat block 2720, authenticating the user as an authorized trainingcandidate for competency training at block 2730, selecting a trainingmodule from the web-based interactive tool corresponding to thecompetency training which the user is authorized to access at block2740, executing a set of at least one skill-based simulated trainingsoftware corresponding to the training module selected from theweb-based interactive tool at block 2750, generating a set of trainingresults for the user upon completion of the training module at block2760, certifying the user is competent to use the agent-dispensingdevice if the set of training results for the user meets or exceeds apre-defined performance threshold at block 2770, and issuing through thebi-directional communication network link an authorization key to theuser to allow the user to deactivate a locking mechanism associated witha controllable agent-dispensing mechanism of the agent-dispensing deviceat block 2780.

In one embodiment, connecting a user to a web-based interactive toolthrough a bi-directional communication network link includes connectingthe user to the web-based interactive tool using one or more of apoint-to-point communication link, a broadcast communication link, amultipoint communication link, a point-to-multipoint communication link,a private communication link, and/or a public communication link. In oneembodiment, the bi-directional communication link includes a data linkfor connecting one location to another for the purposes of transmittingand receiving information. In one embodiment, the bi-directionalcommunication link is an Internet communication link. In one embodiment,the bi-directional communication link is a telephone communication link,non-limiting examples of which include a standard phone line, asymmetricdigital subscriber line (ADSL). In one embodiment, the bi-directionalcommunication link is an intranet communication link. In one embodiment,the bi-directional communication link is a satellite communication link.In one embodiment, the bidirectional communication link includes amicrowave radio relay. In one embodiment, the bi-directionalcommunication link includes at least two communications links selectedfrom the group of communications links consisting of a telephone line,an intranet, the Internet, a satellite, a laser waveform, or a globalpositioning system link.

In one embodiment, receiving authorization information associated withthe user through the bi-directional communication link includesreceiving an authorization code, e.g., a login ID and password, or oneor more biometric parameter, e.g., a fingerprint scan. In oneembodiment, authenticating the user as an authorized candidate forcompetency training includes comparing the received authorizationinformation, e.g., authorization code and/or one or more biometricparameter, with a set of authorization information for authorized users.

In one embodiment, selecting a training module form the web-basedinteractive tool corresponding to the competency training with the useris authorized to access includes selecting a training module based onthe one or more agents to be dispensed, e.g., a first training modulefor a cardiovascular agent and a second training module for an opioidanalgesic. In one embodiment, selecting a training module form theweb-based interactive tool corresponding to the competency trainingwhich the user is authorized to access includes selecting a trainingmodule based on the medical experience of the user, e.g., an abbreviatedtraining module for a medical professional versus a more comprehensivetraining module for a non-medical professional or individual otherwiseunfamiliar with the agent-dispensing device and/or the one or moreagents. In one embodiment, the training module includes one or moreinstructions for proper use of the agent-dispensing device and/or anyassociated agent, non-limiting examples of which include instructionsfor operating and caring for the agent-dispensing device and one or moreinstructions regarding the use and properties of any associated agents.

In one embodiment, executing a set of at least one skill-based simulatedtraining software includes executing a set of text or audio-basedquestions to the user, the set of text or audio-based questions intendedto test the user's knowledge regarding the one or more instructionsprovided in the training module. In one embodiment, executing a set ofat least one skill-based simulated training software include executing aset of instructions for performing one or more operational steps withthe agent-dispensing device while being monitored with an image capturedevice associated with either the computing device or theagent-dispensing device. In one embodiment, executing a set of at leastone skill-based simulated training software includes executing a set ofinstructions for performing one or more operational steps with theagent-dispensing device while one or more use sensors monitor the user'sperformance of the one or more operational steps.

In one embodiment, issuing an authorization key to the user includesissuing an alphanumeric authorization key to the user. The alphanumericauthorization key may be entered into the agent-dispensing device usinga user-device interface. In one embodiment, issuing an authorization keyto the user includes issuing a bar code or QR code onto a display screenof the computing device that is readable by the agent-dispensing device.In one embodiment, the authorization key is a wireless signal sentdirectly to the agent-dispensing device to deactivate the lockingmechanism associated with the controllable agent-dispensing mechanism ofthe agent-dispensing device to allow dispensing of one or more agents.

The state of the art has progressed to the point where there is littledistinction left between hardware, software, and/or firmwareimplementations of aspects of systems; the use of hardware, software,and/or firmware is generally (but not always, in that in certaincontexts the choice between hardware and software can becomesignificant) a design choice representing cost vs. efficiency tradeoffs.There are various vehicles by which processes and/or systems and/orother technologies described herein can be effected (e.g., hardware,software, and/or firmware), and that the preferred vehicle will varywith the context in which the processes and/or systems and/or othertechnologies are deployed. For example, if an implementer determinesthat speed and accuracy are paramount, the implementer may opt for amainly hardware and/or firmware vehicle; alternatively, if flexibilityis paramount, the implementer may opt for a mainly softwareimplementation; or, yet again alternatively, the implementer may opt forsome combination of hardware, software, and/or firmware. Hence, thereare several possible vehicles by which the processes and/or devicesand/or other technologies described herein can be effected, none ofwhich is inherently superior to the other in that any vehicle to beutilized is a choice dependent upon the context in which the vehiclewill be deployed and the specific concerns (e.g., speed, flexibility, orpredictability) of the implementer, any of which may vary. Those skilledin the art will recognize that optical aspects of implementations willtypically employ optically-oriented hardware, software, and or firmware.

In some implementations described herein, logic and similarimplementations can include software or other control structures.Electronic circuitry, for example, may have one or more paths ofelectrical current constructed and arranged to implement variousfunctions as described herein. In some implementations, one or moremedia can be configured to bear a device-detectable implementation whensuch media hold or transmit device detectable instructions operable toperform as described herein. In some variants, for example,implementations can include an update or modification of existingsoftware or firmware, or of gate arrays or programmable hardware, suchas by performing a reception of or a transmission of one or moreinstructions in relation to one or more operations described herein.Alternatively or additionally, in some variants, an implementation caninclude special-purpose hardware, software, firmware components, and/orgeneral-purpose components executing or otherwise invokingspecial-purpose components. Specifications or other implementations canbe transmitted by one or more instances of tangible transmission mediaas described herein, optionally by packet transmission or otherwise bypassing through distributed media at various times.

Alternatively or additionally, implementations may include executing aspecial-purpose instruction sequence or otherwise invoking circuitry forenabling, triggering, coordinating, requesting, or otherwise causing oneor more occurrences of any functional operations described above. Insome variants, operational or other logical descriptions herein may beexpressed directly as source code and compiled or otherwise invoked asan executable instruction sequence. In some contexts, for example, C++or other code sequences can be compiled directly or otherwiseimplemented in high-level descriptor languages (e.g., alogic-synthesizable language, a hardware description language, ahardware design simulation, and/or other such similar mode(s) ofexpression). Alternatively or additionally, some or all of the logicalexpression may be manifested as a Verilog-type hardware description orother circuitry model before physical implementation in hardware,especially for basic operations or timing-critical applications. Thoseskilled in the art will recognize how to obtain, configure, and optimizesuitable transmission or computational elements, material supplies,actuators, or other common structures in light of these teachings.

The foregoing detailed description has set forth various embodiments ofthe devices and/or processes via the use of block diagrams, flowcharts,and/or examples. Insofar as such block diagrams, flowcharts, and/orexamples contain one or more functions and/or operations, it will beunderstood by those within the art that each function and/or operationwithin such block diagrams, flowcharts, or examples can be implemented,individually and/or collectively, by a wide range of hardware, software,firmware, or virtually any combination thereof. In one embodiment,several portions of the subject matter described herein can beimplemented via Application Specific Integrated Circuits (ASICs), FieldProgrammable Gate Arrays (FPGAs), digital signal processors (DSPs), orother integrated formats. However, some aspects of the embodimentsdisclosed herein, in whole or in part, can be equivalently implementedin integrated circuits, as one or more computer programs running on oneor more computers (e.g., as one or more programs running on one or morecomputer systems), as one or more programs running on one or moreprocessors (e.g., as one or more programs running on one or moremicroprocessors), as firmware, or as virtually any combination thereof,and that designing the circuitry and/or writing the code for thesoftware and or firmware would be well within the skill of one of skillin the art in light of this disclosure. In addition, the mechanisms ofthe subject matter described herein are capable of being distributed asa program product in a variety of forms, and that an illustrativeembodiment of the subject matter described herein applies regardless ofthe particular type of signal bearing medium used to actually carry outthe distribution.

In a general sense, those skilled in the art will recognize that thevarious embodiments described herein can be implemented, individuallyand/or collectively, by various types of electro-mechanical systemshaving a wide range of electrical components such as hardware, software,firmware, and/or virtually any combination thereof and a wide range ofcomponents that may impart mechanical force or motion such as rigidbodies, spring or torsional bodies, hydraulics, electro-magneticallyactuated devices, and/or virtually any combination thereof.Consequently, as used herein “electro-mechanical system” includes, butis not limited to, electrical circuitry operably coupled with atransducer (e.g., an actuator, a motor, a piezoelectric crystal, a MicroElectro Mechanical System (MEMS), etc.), electrical circuitry having atleast one discrete electrical circuit, electrical circuitry having atleast one integrated circuit, electrical circuitry having at least oneapplication specific integrated circuit, electrical circuitry forming ageneral purpose computing device configured by a computer program (e.g.,a general purpose computer configured by a computer program which atleast partially carries out processes and/or devices described herein,or a microprocessor configured by a computer program which at leastpartially carries out processes and/or devices described herein),electrical circuitry forming a memory device (e.g., forms of memory(e.g., random access, flash, read only, etc.)), electrical circuitryforming a communications device (e.g., a modem, communications switch,optical-electrical equipment, etc.), and/or any non-electrical analogthereto, such as optical or other analogs. Those skilled in the art willalso appreciate that examples of electro-mechanical systems include butare not limited to a variety of consumer electronics systems and medicaldevices. Those skilled in the art will recognize that electro-mechanicalas used herein is not necessarily limited to a system that has bothelectrical and mechanical actuation except as context may dictateotherwise.

In a general sense, the various aspects described herein can beimplemented, individually and/or collectively, by a wide range ofhardware, software, firmware, and/or any combination thereof and can beviewed as being composed of various types of “electrical circuitry.”Consequently, as used herein “electrical circuitry” includes, but is notlimited to, electrical circuitry having at least one discrete electricalcircuit, electrical circuitry having at least one integrated circuit,electrical circuitry having at least one application specific integratedcircuit, electrical circuitry forming a general purpose computing deviceconfigured by a computer program (e.g., a general purpose computerconfigured by a computer program which at least partially carries outprocesses and/or devices described herein, or a microprocessorconfigured by a computer program which at least partially carries outprocesses and/or devices described herein), electrical circuitry forminga memory device (e.g., forms of memory (e.g., random access, flash, readonly, etc.)), and/or electrical circuitry forming a communicationsdevice (e.g., a modem, communications switch, optical-electricalequipment, etc.). The subject matter described herein can be implementedin an analog or digital fashion or some combination thereof.

Those skilled in the art will recognize that at least a portion of thesystems and/or processes described herein can be integrated into animage processing system. A typical image processing system generallyincludes one or more of a system unit housing, a video display device,memory such as volatile or non-volatile memory, processors such asmicroprocessors or digital signal processors, computational entitiessuch as operating systems, drivers, applications programs, one or moreinteraction devices (e.g., a touch pad, a touch screen, an antenna,etc.), control systems including feedback loops and control motors(e.g., feedback for sensing lens position and/or velocity; controlmotors for moving/distorting lenses to give desired focuses). An imageprocessing system can be implemented utilizing suitable commerciallyavailable components, such as those typically found in digital stillsystems and/or digital motion systems.

Those skilled in the art will recognize that at least a portion of thesystems and/or processes described herein can be integrated into a dataprocessing system. A data processing system generally includes one ormore of a system unit housing, a video display device, memory such asvolatile or non-volatile memory, processors such as microprocessors ordigital signal processors, computational entities such as operatingsystems, drivers, graphical user interfaces, and applications programs,one or more interaction devices (e.g., a touch pad, a touch screen, anantenna, etc.), and/or control systems including feedback loops andcontrol motors (e.g., feedback for sensing position and/or velocity;control motors for moving and/or adjusting components and/orquantities). A data processing system can be implemented utilizingsuitable commercially available components, such as those typicallyfound in data computing/communication and/or networkcomputing/communication systems.

Those skilled in the art will recognize that at least a portion of thesystems and/or processes described herein can be integrated into a motesystem. Those having skill in the art will recognize that a typical motesystem generally includes one or more memories such as volatile ornon-volatile memories, processors such as microprocessors or digitalsignal processors, computational entities such as operating systems,user interfaces, drivers, sensors, actuators, applications programs, oneor more interaction devices (e.g., an antenna USB ports, acoustic ports,etc.), control systems including feedback loops and control motors(e.g., feedback for sensing or estimating position and/or velocity;control motors for moving and/or adjusting components and/orquantities). A mote system may be implemented utilizing suitablecomponents, such as those found in mote computing/communication systems.Specific examples of such components entail such as Intel Corporation'sand/or Crossbow Corporation's mote components and supporting hardware,software, and/or firmware.

In certain cases, use of a system or method may occur in a territoryeven if components are located outside the territory. For example, in adistributed computing context, use of a distributed computing system mayoccur in a territory even though parts of the system may be locatedoutside of the territory (e.g., relay, server, processor, signal-bearingmedium, transmitting computer, receiving computer, etc. located outsidethe territory). A sale of a system or method may likewise occur in aterritory even if components of the system or method are located and/orused outside the territory.

Further, implementation of at least part of a system for performing amethod in one territory does not preclude use of the system in anotherterritory.

One skilled in the art will recognize that the herein describedcomponents (e.g., operations), devices, objects, and the discussionaccompanying them are used as examples for the sake of conceptualclarity and that various configuration modifications are contemplated.Consequently, as used herein, the specific exemplars set forth and theaccompanying discussion are intended to be representative of their moregeneral classes. In general, use of any specific exemplar is intended tobe representative of its class, and the non-inclusion of specificcomponents (e.g., operations), devices, and objects should not be takenlimiting.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations are not expressly set forth herein for sakeof clarity.

The herein described subject matter sometimes illustrates differentcomponents contained within, or connected with, different othercomponents. It is to be understood that such depicted architectures aremerely exemplary, and that in fact many other architectures can beimplemented which achieve the same functionality. In a conceptual sense,any arrangement of components to achieve the same functionality iseffectively “associated” such that the desired functionality isachieved. Hence, any two components herein combined to achieve aparticular functionality can be seen as “operably coupled to” each othersuch that the desired functionality is achieved, irrespective ofarchitectures or intermedial components. Likewise, any two components soassociated can also be viewed as being “operably connected,” or“operably coupled,” to each other to achieve the desired functionality,and any two components capable of being so associated can also be viewedas being “operably couplable,” to each other to achieve the desiredfunctionality. Specific examples of operably couplable include but arenot limited to physically mateable and/or physically interactingcomponents, and/or wirelessly interactable, and/or wirelesslyinteracting components, and/or logically interacting, and/or logicallyinteractable components.

In some instances, one or more components can be referred to herein as“configured to,” “configured by,” “configurable to,” “operable/operativeto,” “adapted/adaptable,” “able to,” “conformable/conformed to,” etc.Those skilled in the art will recognize that such terms (e.g.“configured to”) can generally encompass active-state components and/orinactive-state components and/or standby-state components, unlesscontext requires otherwise.

While particular aspects of the present subject matter described hereinhave been shown and described, it will be apparent to those skilled inthe art that, based upon the teachings herein, changes and modificationscan be made without departing from the subject matter described hereinand its broader aspects and, therefore, the appended claims are toencompass within their scope all such changes and modifications as arewithin the true spirit and scope of the subject matter described herein.

It will be understood by those within the art that, in general, termsused herein, and especially in the appended claims (e.g., bodies of theappended claims) are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that if aspecific number of an introduced claim recitation is intended, such anintent will be explicitly recited in the claim, and in the absence ofsuch recitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to claims containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations. In addition, evenif a specific number of an introduced claim recitation is explicitlyrecited, those skilled in the art will recognize that such recitationshould typically be interpreted to mean at least the recited number(e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to “at least one of A, B, and C, etc.” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, and C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). In those instances where aconvention analogous to “at least one of A, B, or C, etc.” is used, ingeneral such a construction is intended in the sense one having skill inthe art would understand the convention (e.g., “a system having at leastone of A, B, or C” would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that typically a disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms unless context dictates otherwise. For example, the phrase “Aor B” will be typically understood to include the possibilities of “A”or “B” or “A and B.”

Various non-limiting embodiments are described herein as PropheticExamples.

PROPHETIC EXAMPLE 1

A system and method are described for competency training and useauthorization for dispensing oxycodone. A user suffering from moderateto severe chronic pain receives an agent-dispensing device, e.g., apill-dispensing container, filled with oxycodone by certified mail inresponse to a prescription that has been phoned into a dispensingpharmacy by the user's physician. The pill-dispensing container includesa locking mechanism and a controllable agent-dispensing mechanism anduser identification circuitry.

The user receives a URL internet address for a web-based interactivetool via an e-mail communication from the dispensing pharmacy. The useraccesses the web-based interactive tool using his laptop computerequipped with a wireless Internet connection through a router connectedto an Internet provider. The URL Internet address provided by thepharmacy connects the user with the web-based interactive tool.

The user is required to log into the web-based interactive tool usinglogin identification (ID) and a password. A login ID, e.g., the user'sname or email address, and a password are provided to the user from thepharmacy or prescribing physician and are used the first time the userlogs into the web-based interactive tool, but may be changed latter,e.g., to a password that the user is more likely to remember. Once theuser is logged into the web-based interactive tool, he has immediateaccess to one or more of a training module, a verification module,and/or an activation module associated with the tool. If this is thefirst time that the user has used the web-based interactive tool, hisaccess may be restricted to the training module. In this instance thetraining module must be completed before the user is able to access theother modules. If the user is a returning user and feels confident tocomplete the verification process without a training refresher, he maybe able to access the verification module without first going throughthe training module.

The training module includes a series of web-pages with text and imagesproviding information and instructions to the user regarding the properuse of the pill-dispensing container and the oxycodone. The informationincludes material provided in the prescribing information for oxycodone(see, e.g., prescribing information for oxycodone athttp://www.drugs.com/pro/oxycodone.htlm, accessed Apr. 4, 2013 and acopy of which is incorporated herein by reference).

Once the user has been presented all of the material in the trainingmodule regarding the proper use of the pill-dispensing container andoxycodone, e.g., having clicked through all of the appropriate pagesassociated with the training module, the user is directed to theverification module. The verification module includes a multiple choicequestionnaire including a series of 20 or more questions regarding theproper use and care of the pill-dispensing container and the prescribinginformation for oxycodone, including dosage, side-effects, and abusepotential. The verification module tabulates the number of correctresponses to the 20 or more questions and assigns a questionnaire score,e.g., 18, to the user's answers and determines if the score meets orexceeds a pre-defined performance threshold, which in this example is20. Because the user has not met the pre-defined performance threshold,he is required to review all of the training material in the trainingmodule and answer additional questions in the verification module. Oncethe user's questionnaire score reaches 20, the activation moduleprovides a wireless signal to the pill-dispensing container todeactivate a locking mechanism. In this case, however, pills are onlyaccessible when the controllable agent-dispensing mechanism is activatedand this can only occur at specific times of the day and only after theuser's identity has been verified with user identification circuitryassociated with the pill-dispensing container, e.g., a fingerprintscanner associated with or incorporated into the pill-dispensingcontainer. A report is sent via an e-mail to the user's physicianindicating the user's questionnaire scores and whether or not thelocking mechanism of the pill-dispensing container has been deactivated.

PROPHETIC EXAMPLE 2

A system and method are described for competency training and useauthorization for dispensing fentanyl for continuous management ofmoderate to severe pain, e.g., for pain associated with end-stagecancer.

A hospice caregiver providing palliative care for a terminally illindividual in the individual's home receives transdermal fentanylpatches via courier from the sponsoring hospice organization, e.g.,affiliated with a local hospital. The transdermal fentanyl patches arecontained within a box-like structure with a locking mechanism operablylinked to a controllable patch dispensing mechanism, e.g., a rollermechanism which rolls out an individually packaged patch in response topushing a release button on the box-like structure. The lockingmechanism prevents an electrical connection between the actuated releasebutton and the roller mechanism. The box-like structure includes areceiver that is configured to receive a wireless communication, e.g.,an activation signal, from the caregiver's smartphone.

The hospice caregiver accesses a web-based interactive tool using a URLsupplied with the transdermal fentanyl patches. The hospice caregiverenters a personal authorization code as an authorized user of thefentanyl patches and a patient authorization code for the individual whowill be receiving the fentanyl. An authorization module of the web-basedinteractive tool verifies that the authorization codes for the caregiverand the patient are authorized codes and directs the caregiver to atraining module of the web-based interactive tool.

An experienced hospice caregiver is given the option of skipping thetraining material in the training module and going directly to theverification module. Once in the verification module, an audio-basedquestionnaire is administered to the hospice caregiver. The audio-basedquestionnaire includes 20 questions audibly provided to the hospicecaregiver through the speakers of the smartphone. The hospice caregiverprovides short answer responses to the 20 questions and the short answerresponses are compared using voice recognition software associated withthe verification module to determine whether or not each response iscorrect. The verification module assigns a performance score to theresponses to the questionnaire, e.g., the percentage of correctresponses, and determines whether or not the performance score meets orexceeds a pre-defined performance threshold, e.g., 95% correctresponses. If the performance score does not meet 95% correct responses,the hospice caregiver is locked out of the verification module untiltraining material in the training module is reviewed includinginstructions for the use of the transdermal fentanyl patches. If theperformance score does meet or exceed 95% correct responses, then theactivation module of the web-based interactive tool sends a wirelessactivation signal to a receiver of the box-like structure containing thefentanyl patches which in turn sends a signal to deactivate the lockingmechanism to allow engagement of the rolling mechanism in response topushing the release button. In some instances, an additionalalphanumeric code may be required every time the hospice caregiver wantsto access the fentanyl patches from the box-like structure to ensurethat unauthorized individuals are unable to access the patches once thelocking mechanism is deactivated.

PROPHETIC EXAMPLE 3

A device and method are described for competency training and useauthorization for dispensing an inhaled medication from anagent-dispensing device, e.g., an inhaler. The inhaler includes usesensors and circuitry to monitor a series of operational steps forproper use of the inhaler. The inhaler includes a housing with a dockingsite for insertion of a replaceable cartridge containing an asthmamedication, e.g., a bronchodilator. The inhaler further includes amicroprocessor, a power source, switching circuitry, authorizationcircuitry, training circuitry, verification circuitry, activationcircuitry, buttons, and an LED screen display.

Upon receipt of the inhaler, the user powers up the device and enters anauthorization code, e.g., a password, into the inhaler using the buttonsand the LED screen display. The authorization circuitry incorporatedinto the inhaler compares the password entered by the user with storedauthorization codes and allows further access to functions of theinhaler if the user is an authorized user.

If the user has not previously gone through training with the inhaler,the switching circuitry of the inhaler switches the inhaler intotraining mode. In the training mode, operational steps for proper use ofthe inhaler are monitored by use sensors incorporated into the inhalerincluding a motion sensor, one or more pressure sensors, and a timingsensor. The use sensors are configured to monitor motion, e.g., shaking,and pressure, e.g., air flow and pressing of a button, as monitored overtime by the timing sensor. Miniaturized sensors for measuring motion andpressure are known and available from, for example, FreescaleSemiconductor, Inc., Austin, Tex., and Measurement Specialties, Hampton,Va. Non-limiting examples of inhalers with sensors, e.g., airflowsensors, are described in U.S. Pat. No. 5,363,842 and U.S. Pat. No.7,322,355, which are incorporated herein by reference.

The training circuitry provides a step by step list of the operationalsteps for proper use of the inhaler through the LED screen display. Theoperational steps for proper use of the inhaler can include 1) removingcap from the mouth piece, 2) holding inhaler upright, 3) shaking inhaler10-15 times, 4) placing the mouth piece in the mouth, 5) actuating bypressing down on the cartridge in the inhaler, 6) breathing in aspressing down on the cartridge, 7 holding breath, 8) breathing out, and9) repeating if necessary. Once the user has read through the list ofsteps, the user is prompted to go through the operational steps with theinhaler in training mode, the use sensors monitoring one or more of thesteps. A motion sensor, e.g., an accelerometer, is used to monitor themovement associated with shaking the inhaler. A mass air flow sensor(e.g., LMM-H03, Measurements Specialties, Hampton, Va.), measures theflow of air into the inhaler as the user breathes in. A pressure sensormonitors pressure associated with pressing down on the cartridge torelease the bronchodilator from the cartridge. The timing associatedwith inhaling, as measured by the mass air flow and pressing down on thecartridge, as measured by the pressure sensor is noted as part of theperformance. The training circuitry receives input from the use sensorsand assigns a value to each operational step being monitored, e.g., from0-5, where a score of 5 is a perfect performance of the operationalstep.

The verification circuitry determines if each individual assigned valuemeets or exceeds a pre-defined performance threshold for thatoperational step and if the sum of the assigned values meets or exceedsa pre-defined performance threshold for overall performance with theinhaler. If the verification circuitry determines that the appropriatethresholds are met or exceeded, a signal is sent to the activationcircuitry which in turn sends an activation signal to deactivate alocking mechanism of the inhaler to allow dispensing of thebronchodilator. The activation circuitry is further linked to theauthorization circuitry such that the activation signal will only besent if the user is an authorized user.

While various aspects and embodiments have been disclosed herein, otheraspects and embodiments will be apparent to those skilled in the art.The various aspects and embodiments disclosed herein are for purposes ofillustration and are not intended to be limiting, with the true scopeand spirit being indicated by the following claims.

What is claimed is:
 1. An agent-dispensing device comprising: a housingincluding at least one reservoir configured to store one or more agents;a controllable agent-dispensing mechanism in communication with the atleast one reservoir; a locking mechanism coupled to the controllableagent-dispensing mechanism; a microprocessor including circuitry tooperate the agent-dispensing device in a dispensing mode or a trainingmode and switching circuitry operable to switch operation of theagent-dispensing device between the dispensing mode and the trainingmode; one or more use sensors located on the agent-dispensing device andresponsive to at least one operational step for use of theagent-dispensing device in the training mode; training circuitryoperably linked to the one or more use sensors and configured to trainthe user in the at least one operational step for use of theagent-dispensing device in the training mode and to assign a value foreach of the monitored at least one operational step for use of theagent-dispensing device performed by the user in the training mode basedon feedback from the one or more use sensors; verification circuitryconfigured to receive the assigned value for each of the monitored atleast one operational step for use of the agent-dispensing device in thetraining mode, and to certify the user is competent to use theagent-dispensing device if the assigned value for each of the monitoredat least one operational step for use of the agent-dispensing devicemeets or exceeds a pre-defined performance threshold; and activationcircuitry responsive to the verification circuitry and configured todeactivate the locking mechanism if the user is certified competent touse the agent-dispensing device to allow dispensing of the one or moreagents in the dispensing mode.
 2. The device of claim 1, wherein themicroprocessor is operably linked to at least one of the controllableagent-dispensing mechanism, the locking mechanism, the one or more usesensors, the training circuitry, the verification circuitry, or theactivation circuitry.
 3. The device of claim 1, further comprising:authorization circuitry operably linked to the microprocessor andconfigured to authenticate the user as an authorized user of theagent-dispensing device by comparing a user input with a set ofauthorized user inputs.
 4. The device of claim 3, wherein the user inputincludes at least one of an authorization code or a biometric parameter.5. The device of claim 3, wherein the activation circuitry is responsiveto the authorization circuitry and configured to deactivate the lockingmechanism only for an authorized user of the agent-dispensing device. 6.The device of claim 1, wherein the housing includes a hand-held housing.7. The device of claim 1, wherein the at least one reservoir includes atleast one replaceable cartridge configured to be received by a dockingsite associated with the housing of the agent-dispensing device.
 8. Thedevice of claim 7, wherein the agent-dispensing device includescircuitry configured to read a cartridge identification code carried onthe at least one replaceable cartridge.
 9. The device of claim 1,wherein the one or more agents include at least one of one or moretherapeutic agents or one or more preventative agents.
 10. The device ofclaim 1, wherein the one or more use sensors include one or more of anaccelerometer, a timer, an actuator, a pressure sensor, a touch sensor,a temperature sensor, an image capture device, or an inclinometer. 11.The device of claim 1, further comprising: a user-device interfaceoperably connected to one or more of the training circuitry, theverification circuitry, or the activation circuitry.
 12. The device ofclaim 11, wherein the user-device interface is operably connected toauthorization circuitry.
 13. The device of claim 1, wherein the trainingcircuitry includes one or more instructions for the at least oneoperational step for use of the agent-dispensing device, wherein the oneor more instructions are accessible to the user through a user-deviceinterface.
 14. The device of claim 13, wherein the one or moreinstructions include at least one of one or more text-basedinstructions, image-based instructions, audio-based instructions, orvideo-based instructions.
 15. The device of claim 13, wherein the one ormore instructions for the at least one operational step for use of theagent-dispensing device are updateable.
 16. The device of claim 1,wherein the output from the training circuitry is dependent upon one ormore properties of the one or more agents.
 17. The device of claim 1,wherein the training circuitry is configured to receive at least onesignal from the one or more use sensors, the at least one signalincluding information regarding at least one of the monitored at leastone operational step for use of the agent-dispensing device.
 18. Thedevice of claim 1, wherein the verification circuitry includes circuitryconfigured to receive a set of assigned values for each of the monitoredat least one operational step for use of the agent-dispensing devicefrom the training circuitry, and certify the user is competent to usethe agent-dispensing device if each of the set of assigned values foreach of the monitored at least one operational step for use of theagent-dispensing device meets or exceeds the pre-defined performancethreshold.
 19. The device of claim 1, wherein the verification circuitryincludes circuitry configured to receive a set of assigned values foreach of the monitored at least one operational step for use of theagent-dispensing device from the training circuitry, and certify theuser is competent to use the agent-dispensing device if the sum of theset of assigned values for each of the monitored at least oneoperational step for use of the agent-dispensing device meets or exceedsthe pre-defined performance threshold.
 20. The device of claim 1,wherein the pre-defined performance threshold is updateable.
 21. Thedevice of claim 1, wherein the activation circuitry includes circuitryconfigured to receive a user identification and to provide auser-specific activation signal.
 22. The device of claim 1, furthercomprising: a transmission unit including an antenna configured totransmit and receive wireless signals.
 23. A method of verifying usercompetency implemented with circuitry in an agent-dispensing device,comprising: authenticating a user as an authorized user of theagent-dispensing device, wherein the agent-dispensing device includes areservoir configured to store one or more agents, a controllableagent-dispensing mechanism in communication with the reservoir, alocking mechanism coupled to the controllable agent-dispensingmechanism, authorization circuitry, training circuitry, one or more usesensors, verification circuitry, and activation circuitry; training theuser in at least one operational step for use of the agent-dispensingdevice with one or more training instructions included in the trainingcircuitry of the agent-dispensing device; monitoring the user'sperformance of the at least one operational step for use of theagent-dispensing device with the one or more use sensors located on theagent-dispensing device; assigning a value to each of the monitored atleast one operational step for use of the agent-dispensing deviceperformed by the user based on feedback from the one or more use sensorslocated on the agent-dispensing device; verifying with the verificationcircuitry of the agent dispensing device that the user is competent touse the agent-dispensing device if the assigned value for each of themonitored at least one operational step for use of the agent-dispensingdevice meets or exceeds a pre-defined performance threshold; andactivating the agent-dispensing device with the activation circuitry ofthe agent-dispensing device by sending an activation signal todeactivate the locking mechanism coupled to the controllable-agentdispensing mechanism of the agent-dispensing device to allow dispensingof the one or more agents from the agent-dispensing device if the useris verified competent to use the agent-dispensing device.
 24. The methodof claim 23, wherein authenticating the user as an authorized user ofthe agent-dispensing device includes receiving an authorization inputfrom the user with a user-device interface associated with theagent-dispensing device; comparing the received authorization input fromthe user with a set of approved authorization inputs; and unlockingaccess to at least one of the training circuitry, verificationcircuitry, or activation circuitry if the authorization input from theuser satisfies a requirement of at least one of the set of approvedauthorization inputs.
 25. The method of claim 23, wherein training theuser in the at least one operational step for use of theagent-dispensing device with one or more training instructions includedin the training circuitry includes providing the user with one or moreof text, image, audio, or video content including one or moreinstructions for the at least one operational step for use of theagent-dispensing device.